Identity
- Trade Name
- Dental Implantation Instruments EUDAMEDHand Driver FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Device Name
- Dental Implantation Instruments EUDAMED
- Model / Reference
- 069476003000801F4 EUDAMED353020 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06947600316039 EUDAMEDFDA UDI
- Basic UDI-DI
- 069476003000801F4 EUDAMED
- 510(k) Number
- K192274 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implant system
Hand Driver 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
K192274 also covers:
- Abutment screw — BIO CONCEPT Co., Ltd.
- Angled abutment Regular Hex(A type) — BIO CONCEPT Co., Ltd.
- Angled abutment Regular Hex(B type) — BIO CONCEPT Co., Ltd.
- Angled abutment Regular Non-Hex — BIO CONCEPT Co., Ltd.
- Cover screw — BIO CONCEPT Co., Ltd.
- Equator Abutment — BIO CONCEPT Co., Ltd.
- Equator Abutment — BIO CONCEPT Co., Ltd.
- Equator Replacement Male — BIO CONCEPT Co., Ltd.
- Equator Replacement Male — BIO CONCEPT Co., Ltd.
- Healing abutment Regular — BIO CONCEPT Co., Ltd.
- Healing abutment Regular — BIO CONCEPT Co., Ltd.
- Healing abutment Regular — BIO CONCEPT Co., Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 26e4bfd0-a52e-4cb9-97f2-d3183561c0b3 33 fields · synced Jun 19, 2026
- EUDAMED a217c99a-3037-44a8-b58b-07eb0f2f724c 61 fields · synced Jun 19, 2026