Identity
- Trade Name
- STRAUMANN COMPUTER AIDED RESTORATION SERVICE FDA UDI
- Generic Name
- Custom-made dental crown, metal FDA UDI
- Device Name
- Titanium single unit FDA UDI
- Model / Reference
- Copings FDA UDI
- Description
- Titanium single unit FDA UDI
Identifiers
- Catalog Number
- 010.2021 FDA UDI
- Primary DI / UDI-DI
- 07630031728623 FDA UDI
- 510(k) Number
- K052272 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Custom-made dental crown, metal 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Custom-made dental crown, metal
Straumann Computer Aided Restoration Service by Institut Straumann SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Custom-made dental crown, metal.
- Restoration — Modern Dental Laboratory (DG) Co., Ltd. · N
- Restoration — ACESO DENTAL LABORATORY COMPANY LIMITED · N
- Denture, Restoration — ACESO DENTAL LABORATORY COMPANY LIMITED · N
- Restoration — ACESO DENTAL LABORATORY COMPANY LIMITED · N
- Restoration, orthodontic — Modern Dental Laboratory (DG) Co., Ltd. · N
- Denture, retoration — Modern Dental Laboratory (DG) Co., Ltd. · N
- Restoration — ACESO DENTAL LABORATORY COMPANY LIMITED · N
- Restoration — Modern Dental Laboratory (DG) Co., Ltd. · N
Cleared under the same submission
K052272 also covers:
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
- Institut Straumann SA
Sources (1)
- FDA UDI cd0f0010-4fe5-4bf4-970e-f5def66e9d7a 36 fields · synced May 29, 2026