Identity
- Trade Name
- Keystone Keysplint Soft 1Kg FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- Keystone Keysplint Soft 1 Kg FDA UDI
- Model / Reference
- 71186 FDA UDI
- Description
- Keystone Keysplint Soft 1 Kg FDA UDI
Identifiers
- Primary DI / UDI-DI
- D040711861 FDA UDI
- 510(k) Number
- K183598 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
- Not 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Keystone Keysplint Soft 1Kg by Whip-Mix Corp. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Whip-Mix Corp.
Sources (1)
- FDA UDI 6237eb5f-bcb3-4317-8212-b2038c660929 35 fields · synced Jun 8, 2026