Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017399129

FEI Number

3017399129

Entity Name

NEOSS AB

City/State/Country

Goteborg Vastra Gotaland, SE

Establishment Address

Arvid Wallgrens Backe 20, Goteborg Vastra Gotaland 41346, SE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Neoss AB (Owner Number: 10077271)

Owner / Operator Contact Address

Arvid Wallgrens Backe 20, Goteborg, SE-O 41346, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Adjustment handle NeoGen Collagen Firm Neoss PTFE Suture NeoGen Collagen Flex Yomi One Drills, Yomi One Countersinks, Yomi One Instruments and accessories Neoss Instruments and Accessories, Implant Inserter, Screwdriver, Impression Coping, Replica, Scan Body, ScanPeg, Ratchet, Wrench adapter, Neoss Guide, Tack and Screw Cassette, Tack Insertion Pin, Twist Drill, Countersink, Round bur, Lance Drill, Pilot Drill Intra-Oral Scanner, NeoScan

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2026-02-24
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2026-02-24
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-08-19
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2020-08-19
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2020-08-19
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2026-02-24
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-08-19
NBY	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene	General, Plastic Surgery	Class 2	878.5035	2026-02-24
NPM	Bone Grafting Material, Animal Source	Dental	Class 2	872.3930	2026-02-24
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2020-08-19
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2026-02-24
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2023-06-23
NPK	Barrier, Synthetic, Intraoral	Dental	Class 2	872.3930	2020-08-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-08-19
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2026-02-24

Official Correspondent

Maria Lopez

US Agent Details

Cherita James Business: Pro Pharma Group Email: cherita.james@propharmagroup.com Phone: (347) 9540624

Related Public Records

Same Entity

Neoss AB

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
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07
K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01
K925778	Nobelpharma USA, Inc.	BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES	1993-04-14

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-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

Similar Registrations

Registration Number	Establishment Name	Location
3016954909	IMPLANT PROTESIS DENTAL 2004, S.L.	Premia de Dalt Barcelona, ES
3005972890	GoldenDent	Roseville, MI, US
3008808049	SURGICRAFTS	Sialkot Punjab, PK
3010583458	ZOGEAR Medical Co., Ltd.	Yizheng Jiangsu, CN
3012421607	MAINLINE MEDICAL DENTAL SUPPLY	North York Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017399129. Last updated year: 2026. Please use registration number 3017399129 when referencing this establishment in official correspondence.