Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680939

FEI Number

3002807996

Entity Name

RHEIN 83 SRL

City/State/Country

BOLOGNA Emilia-Romagna, IT

Establishment Address

VIA EMILIO ZAGO 10abc, BOLOGNA Emilia-Romagna 40128, IT

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

RHEIN83 SRL (Owner Number: 9012485)

Owner / Operator Contact Address

VIA EMILIO ZAGO 10, BOLOGNA, IT-BO 40128, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

486ICS-US OT STRATEGY EXTR./INSERTION TOOL W. UDI 485IC-US-SIS CAPS EXTR./INSERTION TOOL W. UDI 185SIS-US SEEGER METAL INSERTION TOOL W. UDI 491EC-US CAP EXTRACTOR TOOL W. UDI 774CHE-DIO OT EQUATOR SQUARE SCREW DRIVER + HOLDER 144AE-DIO LABORATORY ANALOGS 2 units 760CRD-US-DIO RATCHET TORQUE CONTROL DEVICE W. UDI 760CRD-US-SIS MANUAL TORQUE WRENCH W. UDI 485IC-US-IQ EQUATOR/OT CAPS INSERTER/EXTRACTOR TOOL 124IMR-US REVERSE 3 INSERTION TOOL W. UDI 488EIP-US-IQ CAPS EXTRACTOR/INSERTION TOOL W. UDI 485IC INSERTION/EXTRACTION TOOL FOR CAPS 085IAC-US CAPS INSERTION TOOL W. UDI 485IC-US CAPS EXTR./INSERTION TOOL W. UDI 760CRD-US MANUAL TORQUE WRENCH W. UDI 044CAIN-DIO IMPRESSION COPING 2 units 488EIP-US CAPS EXTR./INSERTION TOOL W. UDI 472ICV-US OT VERTICAL EXTR./INSERTION TOOL W. UDI 429IOBM-US OT BAR EXTR./INSERTION TOOL W. UDI 485IC-US-DIO MULTIUSE CAP INSERTER/EXTRACTOR TOOL Z-ILZ-ICT IMPRESSION COPING TRANSFER ILZ Z-ILZ-LA LAB ANALOGUE ILZ Z-I-KIT-EQ Insertion-Extraction tool Set EQ 0003-US INSTRUMENT SET (CAI) Z-EQ-ICT IMPRESSION COPING TRANSFER EQ Z-ILZ-HC HEALING CAP TEMP ILZ Z-EQ-LA LAB ANALOGUE EQ OT CAP; OT STRATEGY; OT REVERSE 3; OT EQUATOR PROFILE; SINGLE SPHERE AND ACCESSORIES 141CCN-IQ DENTURE REPLAC.HOUSING ASSEMBLY (4 Pack) 140CEADR8 OT EQUATOR CAP ORANGE INT. ø 2,2MM 4u. 140CEG-IQ EQUATOR RET.CAPS SOFT,YELLOW (4 Pack) 140CER OT EQUATOR PINK CAPS 4u. 140CEN-IQ EQUATOR CAPS LAB.PROCESSING, BLACK (4 p) 140CEG-DIO RETENTIVE CAPS-YELLOW "EXTRA SOFT"-600g 140CEG OT EQUATOR YELLOW CAPS 4u. 192ECE-DIO CAPS ASSORTMENT SET 140CET OT EQUATOR CLEAR CAPS 4u. 141CTE OT EQUATOR TITANIUM HOUSINGS 2u. 140CEN-DIO PROCESSING CAPS-BLACK (for lab.use only) 140CER-IQ EQUATOR RET.CAPS SOFT,PINK (4-Pack) 160EQB THREADED OT EQUATOR SET FOR BONDING 141CAE OT EQUATOR S/STEEL HOUSINGS 2u. 140CEN OT EQUATOR BLACK CAPS (lab.only) 4u. 335SBC-DIO SMART BOX SET 140CEV OT EQUATOR VIOLET CAPS 4u. 092ECQ CASTABLE OT EQUATOR W. CAPS & HOUSING 140CEV-IQ Equator ret.Caps Strong,Violet (4-pack) 140CEDR8 OT EQUATOR CAP AQUA C. INT. ø 2,2MM 4u. 192ECE OT EQUATOR CAPS WITH METAL HOUSING 151SS CASTABLE OT EQUATOR 2u. 158ESA OT EQUATOR SELF-EXTR. ELASTIC SEEGER SET Z-EQ-140CER OT EQUATOR PINK RETENTIVE CAPS 4U. Z-EQ-140CEG OT EQUATOR YELLOW RETENTIVE CAPS 4U. Z-EQ-140CEV OT EQUATOR VIOLET RETENTIVE CAPS 4U. Z-EQ-140CET OT EQUATOR CLEAR RETENTIVE CAPS 4U. Z-EQ-140CEN OT EQUATOR BLACK RETENTIVE CAPS 4U. Z-ILZ-RC5 RETENTIVE CAP 5 pieces Kit ILZ Z-EQ-100PD PROTECTIVE DISK pcs.10 Z-EQ-RC6 RETENTIVE CAP 6 pieces KIT EQ CUFF HEIGHT MEASURER Z-EQ-SBOX Retentive EQ Cap Set PIVOT FLEX PIVOT BLOCK; OT REVERSE 3 Z-EQ-131TN433 Equator Tri-Nex ø4.3 x 3mm Kit Z-EQ-131TN357 Equator Tri-Nex ø3.5 x 7mm Kit Z-EQ-131TN356 Equator Tri-Nex ø3.5 x 6mm Kit Z-EQ-131TN437 Equator Tri-Nex ø4.3 x 7mm Kit Z-EQ-131TN353 Equator Tri-Nex ø3.5 x 3mm Kit Z-EQ-131TN53 Equator Tri-Nex ø5 x 3mm Kit Z-EQ-131TN55 Equator Tri-Nex ø5 x 5mm Kit Z-EQ-131TN436 Equator Tri-Nex ø4.3 x 6mm Kit Z-EQ-131TN432 Equator Tri-Nex ø4.3 x 2mm Kit Z-EQ-131TN351 Equator Tri-Nex ø3.5 x 1mm Kit Z-EQ-131TN51 Equator Tri-Nex ø5 x 1mm Kit Z-EQ-131TN352 Equator Tri-Nex ø3.5 x 2mm Kit Z-EQ-131TN52 Equator Tri-Nex ø5 x 2mm Kit Z-EQ-131TN431 Equator Tri-Nex ø4.3 x 1mm Kit 030AS4NC3-DIO DIO Implant UF-UFII Regular Int. Type Z-EQ-131TN355 Equator Tri-Nex ø3.5 x 5mm Kit Z-EQ-131TN56 Equator Tri-Nex ø5 x 6mm Kit Z-EQ-131TN57 Equator Tri-Nex ø5 x 7mm Kit Z-EQ-131TN354 Equator Tri-Nex ø3.5 x 4mm Kit Z-EQ-131TN54 Equator Tri-Nex ø5 x 4mm Kit Z-EQ-131TN435 Equator Tri-Nex ø4.3 x 5mm Kit Z-EQ-131TN434 Equator Tri-Nex ø4.3 x 4mm Kit BROKEN SCREW EXTRACTOR KIT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-10-18
EJX	Anchor, Preformed	Dental	Class 1	872.3130	1995-02-22
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2013-11-08
EGG	Attachment, Precision, All	Dental	Class 1	872.3165	2013-11-07
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2013-11-22
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-12-13
ELR	Post, Root Canal	Dental	Class 1	872.3810	2013-11-08
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-01-26
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2013-11-08

Official Correspondent

GIANNI STORNI

US Agent Details

Joseph J. Tambasco Business: American Recovery Email: jtambasco@american-recovery.com Phone: (914) 6323800

Related Public Records

Same Entity

RHEIN83 SRL

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Z-0013-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

Similar Registrations

Registration Number	Establishment Name	Location
3013578168	DDS CARIBBEAN CORP	Guaynabo, PR, US
3030690317	TRATE LLC	Tamarac, FL, US
3011587077	JIANGSU TRAUSIM MEDICAL INSTRUMENT CO.,LTD.	Changzhou Jiangsu, CN
3012121192	DENTAL EVOLUTIONS, INC	Beverly Hills, CA, US
3031529635	TRATE UAB	Kaunas Kauno Apskritis, LT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680939. Last updated year: 2026. Please use registration number 9680939 when referencing this establishment in official correspondence.