Identity
- Trade Name
- Diamond D FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- Denture Acrylic SC Orig Pwd FDA UDI
- Model / Reference
- 1013052 FDA UDI
- Description
- Denture Acrylic SC Orig Pwd FDA UDI
Identifiers
- Catalog Number
- 1013052 FDA UDI
- Primary DI / UDI-DI
- H66810130521 FDA UDI
- 510(k) Number
- K032773 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Dental appliance fabrication material, resin 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
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
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 25 Pound FDA UDIWeight — 11.34 Kilogram FDA UDI
Category: Dental appliance fabrication material, resin
Diamond D by Keystone Industries — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental appliance fabrication material, resin.
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- smartrepair A2 — DETAX GmbH & Co. KG · Class IIa
- BASIS HI — YAMAHACHI DENTAL MFG., CO. · Class II
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Cleared under the same submission
K032773 also covers:
- Diamond D — Keystone Industries
- Diamond D — Keystone Industries
- Diamond D — Keystone Industries
- Diamond D — Keystone Industries
- Diamond D — Keystone Industries
- Diamond D — Keystone Industries
- Diamond D — Keystone Industries
- Diamond D — Keystone Industries
- Diamond D — Keystone Industries
- Diamond D — Keystone Industries
- Diamond D — Keystone Industries
- Diamond D — Keystone Industries
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
- Keystone Industries
Sources (1)
- FDA UDI be78753c-66fd-4fc1-a9fd-df6618f0869c 37 fields · synced Jun 9, 2026