Identity
- Trade Name
- CM LOC® FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- 05001424 CM LOC® Abutment Nobel Biocare Replace Select® NP 3.5 GH2 35Ncm . The CM LOC® is used for the following clinical situations: • CM LOC® Abutment: Implant anchorage of hybrid-supported removable dental prostheses on implants. • CM LOC® CAD CAM Retention Element: As an additional retaining element on CAD CAM milled dental bars. • divergence up to 30 degrees per implant with CM LOC® FDA UDI
- Model / Reference
- 05001424 FDA UDI
- Description
- 05001424 CM LOC® Abutment Nobel Biocare Replace Select® NP 3.5 GH2 35Ncm . The CM LOC® is used for the following clinical situations: • CM LOC® Abutment: Implant anchorage of hybrid-supported removable dental prostheses on implants. • CM LOC® CAD CAM Retention Element: As an additional retaining element on CAD CAM milled dental bars. • divergence up to 30 degrees per implant with CM LOC® FDA UDI
Identifiers
- Catalog Number
- 05001424 FDA UDI
- Primary DI / UDI-DI
- 07640166510703 FDA UDI
- 510(k) Number
- K130618 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
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
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Height — 2 Millimeter FDA UDI
Category: Dental implant suprastructure, permanent, preformed
Cm Loc® by Cendres+Métaux SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
- SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
- HS/HG Prosthetic System — OSSTEM IMPLANT Co., Ltd. · Class II
- DESS dental smart solutions — TERRATS MEDICAL SL. · Class II
- 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
- EZ Post — Megagen Implant Co. Ltd · Class II
Cleared under the same submission
K130618 also covers:
- CM LOC® — Cendres+Métaux SA
- CM LOC® — Cendres+Métaux SA
- CM LOC® — Cendres+Métaux SA
- CM LOC® — Cendres+Métaux SA
- CM LOC® — Cendres+Métaux SA
- CM LOC® — Cendres+Métaux SA
- CM LOC® — Cendres+Métaux SA
- CM LOC® — Cendres+Métaux SA
- CM LOC® — Cendres+Métaux SA
- CM LOC® — Cendres+Métaux SA
- CM LOC® — Cendres+Métaux SA
- CM LOC® — Cendres+Métaux SA
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
- Cendres+Métaux SA
Sources (1)
- FDA UDI f493806e-10f5-4da6-9f17-1c4ef28709a6 36 fields · synced Jun 7, 2026