SCS Screwdriver for ratchet, extra short
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Dental Implantation Instruments EUDAMEDSCS Screwdriver for ratchet, extra short FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Device Name
- Dental Implantation Instruments EUDAMED
- Model / Reference
- 069476003000801F4 EUDAMED054010 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06947600301813 EUDAMEDFDA UDI
- Basic UDI-DI
- 069476003000801F4 EUDAMED
- 510(k) Number
- K150388 FDA UDI
- FDA Product Code
- DZE 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
- 872.3640 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
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
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Dental implant system
SCS Screwdriver for ratchet, extra short 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
K150388 also covers:
- Adapter for ratchet, extra short — BIO CONCEPT Co., Ltd.
- Alignment pin, Φ 2.2mm — BIO CONCEPT Co., Ltd.
- BL Implant Distance Indicator — BIO CONCEPT Co., Ltd.
- Bone Level Implant — BIO CONCEPT Co., Ltd.
- Bone Level Implant — BIO CONCEPT Co., Ltd.
- Bone Level Implant — BIO CONCEPT Co., Ltd.
- Equator Abutment, Φ 4.8mm, GH 1mm — BIO CONCEPT Co., Ltd.
- Equator Abutment, Φ 4.8mm, GH 1mm — BIO CONCEPT Co., Ltd.
- Equator Abutment, Φ 4.8mm, GH 3mm — BIO CONCEPT Co., Ltd.
- Equator Abutment, Φ 4.8mm, GH 5mm — BIO CONCEPT Co., Ltd.
- Equator Abutment, Φ 6.5mm, GH 2mm — BIO CONCEPT Co., Ltd.
- Equator Abutment, Φ 6.5mm, GH 2mm — 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 cd2c70ff-7825-4ca4-b02e-71f797e11b69 33 fields · synced Jun 11, 2026
- EUDAMED 0b9edb1b-a1e6-4161-ba86-8b31559fb225 61 fields · synced Jun 11, 2026