Identity
- Trade Name
- NR Line FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Abutment, Implant, Dental, Endosseous FDA UDI
- Model / Reference
- GCMAB10R FDA UDI
- Description
- Abutment, Implant, Dental, Endosseous FDA UDI
Identifiers
- Catalog Number
- GCMAB10R FDA UDI
- Primary DI / UDI-DI
- 08809162709224 FDA UDI
- 510(k) Number
- K170384 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental implant suprastructure, permanent, preformed
NR Line by Dentium Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
- SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
- HS/HG Prosthetic System — OSSTEM IMPLANT Co., Ltd. · Class II
- DESS dental smart solutions — TERRATS MEDICAL SL. · Class II
- Diamodent — Diamodent · Class II
- Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
Cleared under the same submission
K170384 also covers:
- NR Line — Dentium Co., Ltd.
- NR Line — Dentium Co., Ltd.
- NR Line — Dentium Co., Ltd.
- NR Line — Dentium Co., Ltd.
- NR Line — Dentium Co., Ltd.
- NR Line — Dentium Co., Ltd.
- NR Line — Dentium Co., Ltd.
- NR Line — Dentium Co., Ltd.
- NR Line — Dentium Co., Ltd.
- NR Line — Dentium Co., Ltd.
- NR Line — Dentium Co., Ltd.
- NR Line — Dentium Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dentium Co., Ltd.
Sources (1)
- FDA UDI a359f811-6c61-452a-ac1d-d8d331fda0cc 36 fields · synced May 30, 2026