Identity
- Trade Name
- Customized Abutment and Screw FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Model / Reference
- QU-02 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06932195385263 FDA UDI
- 510(k) Number
- K242768 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
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
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
Customized Abutment and Screw by Chengdu Besmile Medical Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental implant suprastructure, permanent, preformed.
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- 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
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Cleared under the same submission
K242768 also covers:
- Customized Abutment and Screw — Chengdu Besmile Medical Technology Co., Ltd.
- Customized Abutment and Screw — Chengdu Besmile Medical Technology Co., Ltd.
- Customized Abutment and Screw — Chengdu Besmile Medical Technology Co., Ltd.
- Customized Abutment and Screw — Chengdu Besmile Medical Technology Co., Ltd.
- Customized Abutment and Screw — Chengdu Besmile Medical Technology Co., Ltd.
- Customized Abutment and Screw — Chengdu Besmile Medical Technology Co., Ltd.
- Customized Abutment and Screw — Chengdu Besmile Medical Technology 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 |
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Manufacturer
- Manufacturer
- Chengdu Besmile Medical Technology Co., Ltd.
Sources (1)
- FDA UDI c42f0255-e74d-4158-8f9e-a1cd8ac22654 33 fields · synced May 30, 2026