Holding key for screw-retained abutment
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Dental Implantation Instruments EUDAMEDHolding key for screw-retained abutment FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Device Name
- Dental Implantation Instruments EUDAMED
- Model / Reference
- 069476003001701F6 EUDAMED155010 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06947600309086 EUDAMEDFDA UDI
- Basic UDI-DI
- 069476003001701F6 EUDAMED
- 510(k) Number
- K212364 FDA UDI
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental implant system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental implant system
Holding key for screw-retained abutment by BIO CONCEPT Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant system.
- Ball Attachment 5 mm — NOGA MEDICAL PRODUCTS LTD · Class II
- Short Abutment — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
- Magicore — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
- Magicore S — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
- TRI — Tri Dental Implants Int. AG · Class II
- Denture Retention Attachments — IMPLANT ATTACHMENTS LLC · Class II
- Chaorum Implant System — Medimecca Co., Ltd. · Class II
- JDEvolution Plus — Jdentalcare Srl · Class II
Cleared under the same submission
K212364 also covers:
- Alignment Pin — BIO CONCEPT Co., Ltd.
- BLT Drill, short — BIO CONCEPT Co., Ltd.
- BLT Drill, short — BIO CONCEPT Co., Ltd.
- BLT Pilot Drill, extra-short — BIO CONCEPT Co., Ltd.
- BLT Pilot Drill, long — BIO CONCEPT Co., Ltd.
- BLT Pilot Drill, short — BIO CONCEPT Co., Ltd.
- BLT Profile Drill, short — BIO CONCEPT Co., Ltd.
- Bone Level Tapered Implant — BIO CONCEPT Co., Ltd.
- Bone Level Tapered Implant — BIO CONCEPT Co., Ltd.
- Bone Level Tapered Implant — BIO CONCEPT Co., Ltd.
- Bone Level Tapered Implant — BIO CONCEPT Co., Ltd.
- Bone Profiler 1 — BIO CONCEPT Co., Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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
- BIO CONCEPT Co., Ltd.
Sources (2)
- FDA UDI cc2783f6-8475-4c37-8efc-399ca68a2fbe 33 fields · synced Jul 27, 2026
- EUDAMED c93dda1c-1d4a-46ab-b92a-033fce32af87 61 fields · synced Jul 27, 2026