Identity
- Trade Name
- Silk Line Kit FDA UDI
- Generic Name
- Denture reliner, soft, professional FDA UDI
- Device Name
- Soft Denture Relining Material FDA UDI
- Model / Reference
- 28100100 FDA UDI
- Description
- Soft Denture Relining Material FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10852253006134 FDA UDI
- 510(k) Number
- K060844 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Denture reliner, soft, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 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
Yes
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
Category: Denture reliner, soft, professional
Silk Line Kit by J. Morita U.s.a., Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Denture reliner, soft, professional.
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Cleared under the same submission
K060844 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 |
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Manufacturer
- Manufacturer
- J. Morita U.s.a., Inc
Sources (1)
- FDA UDI c68165b5-578f-4809-980e-12d949433e7c 34 fields · synced May 30, 2026