Identity
- Trade Name
- DURAGUARD FDA UDI
- Generic Name
- Dental implant x-ray template FDA UDI
- Device Name
- DURAGUARD CLEAR .160 (4mm) ROUND 25PK FDA UDI
- Model / Reference
- DGSC160X25R FDA UDI
- Description
- DURAGUARD CLEAR .160 (4mm) ROUND 25PK FDA UDI
Identifiers
- Catalog Number
- DGSC160X25R FDA UDI
- Primary DI / UDI-DI
- D746DGSC160X25R1 FDA UDI
- FDA Product Code
- MQC FDA UDI
- GMDN Term
- Dental implant x-ray template FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Duraguard by Dentsply Sirona Orthodontics Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 U | Pending data |
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Manufacturer
- Manufacturer
- Dentsply Sirona Orthodontics Inc.
Sources (1)
- FDA UDI 6cc4a797-f0bd-4034-9ccf-61cc09e25c4a 36 fields · synced Jun 9, 2026