Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611253

FEI Number

3002807687

Entity Name

NAKANISHI INC.

City/State/Country

Kanuma Tochigi, JP

Establishment Address

700 SHIMOHINATA, Kanuma Tochigi 322-8666, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NAKANISHI INC. (Owner Number: 8030216)

Owner / Operator Contact Address

700 Shimohinata, Kanuma, JP-09 322-8666, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K011926

PMA Number

N/A

All Registered Proprietary Names

S21R S950KL S900L S900 V-U25 S20 V-U15 S900KL S950SL S2 S75 S21L S950 SONIC SCALER WITH FIBER OPTIC S900SL V-U20 S950WL S950L V-U35 S3 S900K LAD S35 V-U30 S950BL AS2000 B2/3 S10 AS2000 M4 S1 PTL-CL-LED Pana-Max2 M4 FM-CL-M4-T S-Max pico WLED M900WL M800L QD-J M4 M800 S-Max pico KL M900L KCL-LED FM-CL-M4 PTL-CL-FV-T M800KL M900K QD-J B2/B3 S-Max pico SL M900W S-Max pico M800WL M900 M900KL PTL-CL-LED III S-Max pico BLED PAP2-MU M4 PAP2-SU M4 PMNG-BA-P PMN-HP PMNG-SR-P PMNG-B2-P PMNW-PTL-P PMNG-KV-P PMNG-PTL-P Prophy-Mate neo PMNW-B2-P PMNG-WH-P PMNG-M4-P ELEC-MATE NE134 VA750 120S VA750LUX120S VA750 120 VA750LUX230S Varios 75 VA750 230S MPA-F20R EM13M EMD120VS MPA-F10R EMT2230VE1 EMT120V1 EMT2120VS TWZ120V1 TWZ120VS NML-F4R NML-F16R EMT120V2 EMD230V1 ENDO-MATE 2 NT120 TWZ120V2 MP-F10R TEP-F NE131 MPAS-F20R PROPHY-MATE EMD120V1 MP-F20R NAC-F4R MPA-F4R EVA-F EMT2120V1 EMT230V1 MP-F16R ARS-F4R VM-F MPAS-F4R TEQ-F ENDO-MATE 2 NML-F10R EM10M2 EMD MPA 120V MPAS-F16R NML-F20R MP-F TASKAL 7 EMT120V3 MPA-F16R TW10M EM10M ARK-F4R Ti55 X35 Ti95LA E-TYPE SPEED INCREASER CONTRA ANGLE Ti85LA X20 Ti85L X95EX X10 Ti35 Ti95 Ti15 Ti85 Ti55L Ti15L Ti45L X75L X70 X10L FPB-E X55L Ti25LA M65 X70L Ti95EX Ti75 Ti95L ES-95 Ti10 X75 Ti70L Ti25L Ti25 Ti20L Ti57 X35L X57L X57 X55 Ti10LA Ti45 Ti35L Ti20 NE171 VA560LUX230S VA560 230S VA560 120S ULTRASONIC SCALER VARIOS 560 VA560LUX120S Surgic XT SG14L SG15C SG11 SG12 SG5 SG1 SG8A SG2R H-SG8 M-RE2 SCL4D SG2L SG9 VSRG120V1 VA-SGN-HPSC E30LD-S H-SG8R SG4 VarioSurg VSRG OPT (120V) SG19 SG10 SCL1D SG16A SG1A SCL5 VS-LED-HPSC P25R-S SG6D SCL1 SG15A SG7D VSRG230V1 NE214 SG18L H-SG8L M-ST1 SCL3D V10-S E32D-S SCL5D SCL2D E31D-S VSRG120V2 H-SG1 SG68 P25L-S M-OC1L SG16B SG15D SG14R SG18R SG30 SG3 SCL3 M-OC1R E30RD-S G1-S VarioSurg-HPSC SG58 SG17 SG15B P20-S SG8 X85 nano95LS X25 X95 Z85L M25 M95L M15 X25L M95 X85L X15 X95L Z15L X12 Z25L X20L M15L M25L X15L nano25LS Z10L X12L IS-205 M4 EX-203 M4 PTL-950Ti EX-203C B2 FX205 B2 EX-203 B2 FX204 M4 Ti205L EX-204 M4 EX-203C M4 EX-103 M4 PTL-CR iProphy Air PTL-CD PTL-950 PTL-SDN(W/O FIBER) EX-117 AIR MOTOR HANDPIECE TN-102 FX205 M4 IS-205 B2/3 NSK PUSH-BUTTON MIDWEST REPLACEMENT iSD-HP EM10M3 iSD120V1 Primado Bur PANA SPRAY Plus SG70M Surgic Pro+ OPT(120V) X-SG20L Surgic Pro OPT(230V) Surgic Pro OPT(120V) Surgic Pro NON-OPT(120V) FC-78 X-SG20ML SG20M SG20 SGL70M SGS-E SGS-ES SGA-ES SGA-E2S SGS-E2G SGS-E2S SGA-E2G SGA-E Ti-Max Z45 Z45L iCare Care3 Plus C0TYPE 120V Care3 Plus C3TYPE 120V Care3 Plus C1TYPE 120V Care3 Plus C1TYPE 230V Care3 Plus C2TYPE 120V Care3 Plus Prophy Kit2 FC-83 Powder Handpiece(For Prophy use) Powder Handpiece(For Perio use) Varios Combi Pro2 Basic Set Perio Kit2 EX-5B FX65K FX50m X65 M65 X65L FX65 FX50K Prophy-Mate PM-KV-S PM-B2-L PM-KV-L PM-PTL-L PM-BA-L PM-WH-L PM-B2-S PM-B2 PM-WH-S PM-PTL-S PM-M4-S PM-M4 PM-M4-L Ti65 Ti-ENDO Ti65L SGMS-ER20i TEP-ER10 BB-EC FX65 N-30U EX-5B NM-E64R X65L EX-ENDO 128 NAC-EC NBBW-EC TEP-E10R EX-6D NBBW-E EX-6B NAC-E16R EX-5 FFB-EC E-TYPE CONTRA ANGLE NAC-E FPB-ECM MP-ER64 TEQ-E10R ARK-2 NM-EC EX-6 FPB-EC EX-6BM NM-E FX75 EX-6L FX23 X65 Ti65LA EX-8 ARS-1 X-SG25L X-SG93 X-SG93L SGO-2 SGM-E256RI SGO-3 SGP-E32RI SG256TL55 STR SGP-E256RI X-DSG20 Ti-SG20L X-SG65 SGO-5 SGQ-ER20h SGM-ER64i SGO-6 SGT-E X-DSG20h Ti-SG25L X-DSG20Lh SGM-ER32i SGO-1 X-DSG20L Ti-SG20 SGR2-E SGO-4 SGP-E20RI SGMS-ER20i SGO-E SGP-E10RI SGP-E64RI SGM-E20RI SGO2-E SGT2-E X-SG65L SGM-ER256i SGR-E SGP-E16RI SGM-ER20i Ti-SG65L E-TYPE SPEED REDUCER CONTRA ANGLE SGM-E10RI SGM-E16RI SGM-ER16i FX204 M4 M205 Surgic IV Implant Control Unit Surgic XT Plus 230V OPT SurgicXTSTT120ERMS Surgic XT P12 SurgicXT Plus W/O(120V) Surgic XT Plus 120V LED Surgic XTS120 Surgic AP S 120 Surgic AP S 230 Surgic XT Plus 230V N-OPT SG50MS Motor Surgic AP(120V) Surgic XTSTT230ERMS SGL50M Motor Surgic XTSTT120MS w/o HP SG50LED Surgic XTSTT120ERMS Surgic XT Plus 120V N-OPT SurgicXTSTT120MS without Handpiece Surgic XT12 w/o HP SGL50M Surgic XT P23 SG50M SG50MS NE179 Surgic XT Plus 120V OPT VA170S11 VA170LUXS10 VA170LUXS11 VarioSurg 4 (120V) FC-86 VarioSurg 4 w/o FC (120V) VS4-LED-HPSC UBS-RCD130C2-40 UBS-RD130C3-45 UBS-RD130C3-30 UBS-RD50C2-15 UBS-RD130C3-40 UBS-RD70C1-30 UBS-RD70C2-06 UBS-RCD130C2-30 UBS-RD70C1-20 UBS-RD70C2-15 UBS-RD70C2-07 UBS-RD50C2-07 UBS-RD70C2-10 UBS-RCD130C3-40 UBS-RD130C2-45 UBS-RCD130C2-45 UBS-RD50C2-10 UBS-RD50C1-20 UBS-RCD130C3-30 UBS-RD50C2-06 UBS-RD50C1-30 UBS-RD130C2-40 UBS-RD70C2-08 UBS-RD50C2-08 UBS-RD130C2-30 UBS-RCD130C3-45 VA370NA VA370ADNA Forza V3 VA370LUXADNA VA370 SY-LUX-HP VA370LUXNA Forza V3 LED VA370 Lux Varios 370 Primado Primado FX58m FX20m FX55m FX25 FX57K FX20K FX25K FX22 FX15 FX57 PER-PTL-P Perio Mate Nozzle Tip PER-KV-P PER-M4-P V-G76 G12 V10 P1 V-P26R P26L P25R G1 G62D P40 V-G77 P21R VARIOS G9 G2-E V10-E VA970 120V V-G87 E4 G67D P1D G22 P20 V-G72 P3D G21 G4 G7 P21L V-S51D E30LD G5 G16 U files 33mm ISO 30 VA2-LUX-SC Ti VA970 LUX 120V V-S53 U files 33mm ISO 35 P26R V-S50 V-S52D G68D E31D G28 VA170-SC P25R-E Tip Cap E7 P21R-E G65D G66D E5 V-S3 V-G71 U files 33mm ISO 15 E8 P25L-E V-G79 VA170LUX-SC G2 E12 E32D V-N50 Varios 970 Unit NA V-S53D V-S50D U files 33mm ISO 20 E9D G61D G13 V-G70 P11L E14D V-P11L V-P12 G26 G11 E15D P41 V-P10 V-S1 Varios 970 V-G78 G3-E V-P26L G3 V-P11R G8 E7D G1-E V-G75 G6-E P11R E30RD V30 G25 P20-E E4D P2D G6 V-G82 V-S51 V-N51 U files 33mm ISO 25 V-S52 G4-E E8D P25L E11 P10 E9 V-S33 P21L-E E6 S-Max M500K MC-E TU B2/3 PAE-SU M N-75S AK400L Ti-Max A500L Ti-Max A700 N-75T MLXT-MU PAE-S M4 PAP-MU M4 S-Max M600KL N-75M Ti-Max AK600L S-Max M500BL S-Max M600K ML-XT TU PE-MS NL-75M MC-QD SU CH45-QD PAE-TU B2 ML-XT MU M600LG M4 S-Max M500L M500LG B2 AK455L TU AT450 B2 N-45S M600LG B2 S-Max pico MWL Ti-Max A500 PTL-MS MC-E SU B2/ PAP-SU B2 S-Max M500WL Ti-Max A600L Ti-Max AK700L S-Max M600 PAP-SU 5H PAE-TU M4 PANA AIR E M PAP-SU M4 PANA-MAX SU M4 MC-QD TU AS455L TU PAP-MU B2 MC2-MU ALPHA AIR HANDPIECE, ULTRA-PUSH, AL S-Max M600L Ti-MaxNL-95W T(BRA) S-Max M500 AW450L SU NL-75T Ti-Max A700L AW300L S-Max M600BL PA2000 SU M4 Ti-MaxNL-95W M(BRA) PAE-T B2 A450L MC2-SU S-Max M500SL AS450L SU PANA-MAX TU B2 S-Max M500KL S-Max M600WL Ti-Max A600 S-Max M600BLED AT450 M4 AK450L SU S-Max pico STL PHATELUS 45 SU S-Max M600WLED PANA-MAX SU B2 PANA-MAX TU M4 AB450L SU MLXT-TU S-Max M600SL PAE-M M4 S-Max pico WHL PAE-M B2 MLXT-SU AW455L TU MC2-EMU B2 PAE-SU B2 PHATELUS 45 TU PAE-S B2 PAP-MU 5H PAE-T M4 N-45T PAE-MU B2 NLX nano S120E NE188 Ti-Max NL400MC TIM40S NLX nano NL400S120 NE210 NL400S120E NL400SBSET2BEL NL400B SET 5 TAKARA BELMONT NL400BSET7NORAC TI-MAX TIM40J NLX nano S120 NE136 NL400BSET5PCB EL400JS120 Ti-Max NL400 T-Force DA-700 EL400S120 TI-MAX TIM40 NE278 nano400 NE161 ELM40M

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2008-03-18
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2022-10-19
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2012-02-14
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2008-03-18
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2008-05-16
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2008-03-18
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2007-05-18
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2008-03-18
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2008-03-18
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2018-02-05
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2008-03-27
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2008-07-10
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2008-07-10
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2019-05-30
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2008-03-18
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2008-03-18
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2013-11-29
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2009-05-04
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2018-08-30
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2018-07-20
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2018-07-20
KMW	Handpiece, Rotary Bone Cutting	Dental	Class 2	872.4120	2018-07-20
KMW	Handpiece, Rotary Bone Cutting	Dental	Class 2	872.4120	2018-01-10
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2018-01-10
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2013-11-29
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2009-01-26
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2026-03-12
KOJ	Airbrush	Dental	Class 2	872.6080	2026-03-12
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2023-08-30
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2008-04-17
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2008-03-18
KMW	Handpiece, Rotary Bone Cutting	Dental	Class 2	872.4120	2022-01-24
KMW	Handpiece, Rotary Bone Cutting	Dental	Class 2	872.4120	2008-03-18
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2024-05-01
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2008-03-18
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2014-11-20
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2025-09-22
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2025-12-25
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2025-12-25
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2025-09-21
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2025-09-21
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2025-09-21
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2013-05-16
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2018-02-05
HAB	Saw, Powered, And Accessories	General, Plastic Surgery	Class 1	878.4820	2008-06-09
DWI	Saw, Electrically Powered	General, Plastic Surgery	Class 1	878.4820	2008-06-09
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2023-03-02
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2024-09-24
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2015-11-30
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2013-11-29
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2008-04-07
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2008-03-18
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2019-06-13
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2015-02-04

Official Correspondent

JungHee Kim

US Agent Details

SEAN KAUFMAN Business: NSK AMERICA CORPORATION Email: nskra@nsk-nakanishi.co.jp Phone: (888) 6751675

Related Public Records

Same Entity

NAKANISHI INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1422375	NSK AMERICA CORP.	Hoffman Est, IL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K832443	California Technics, Inc.	ULTRASONIC DENTAL PROPHYLAXIS UNIT	1983-09-12
K994299	Bonart Co., Ltd.	ART-P3, MODEL P3-1-ART-A1	2000-03-06
K212910	Shenzhen Carejoy Technology Co., Ltd.	Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece	2022-11-17
K040153	Indigenous Peoples Technology and Education Center	I-TEC PORTABLE DENTAL OPERATORY	2004-05-21
K241065	Dentis Co., Ltd.	ChecQ (AC100)	2025-03-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026	S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil	2	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	2	Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Z-0029-05	Implant Innovations, Inc.	2	EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611253. Last updated year: 2026. Please use registration number 9611253 when referencing this establishment in official correspondence.