Identity
- Trade Name
- Glidewell TuffSplint™ Appliance Resin FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- Glidewell TuffSplint™ Appliance Resin FDA UDI
- Model / Reference
- 70-1164-RSN0007 FDA UDI
- Description
- Glidewell TuffSplint™ Appliance Resin FDA UDI
Identifiers
- Catalog Number
- 70-1164-RSN0007 FDA UDI
- Primary DI / UDI-DI
- D745701164RSN00070 FDA UDI
- 510(k) Number
- K223798 FDA UDI
- FDA Product Code
- KMY FDA UDIMQC FDA UDI
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5525 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Category: Dental appliance fabrication material, resinOrthodontic retainer
Glidewell TuffSplint™ Appliance Resin by Prismatik Dentalcraft, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Prismatik Dentalcraft, Inc.
Sources (1)
- FDA UDI 706dd78a-ab45-4d88-97ec-601d83716ab7 36 fields · synced Jun 8, 2026