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RC Impression Post Opened Tray, long, non-engaging
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- RC Impression Post Opened Tray, long, non-engaging FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Model / Reference
- 162110N FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06947600303954 FDA UDI
- 510(k) Number
- K212364 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant system 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental implant system
RC Impression Post Opened Tray, long, non-engaging by BIO CONCEPT Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — 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 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.
- Bone Profiler 3 — BIO CONCEPT 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
- BIO CONCEPT Co., Ltd.
Sources (1)
- FDA UDI 07609ed5-2c31-43c8-b36c-02d8aa5574ad 33 fields · synced May 30, 2026