Identity
- Trade Name
- Diamond D Ultra Impact Denture Acrylic EUDAMEDDiamond D FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- Dental Acrylic EUDAMEDDenture Acrylic HC Orig 1 lb P& L FDA UDI
- Model / Reference
- 1013061 EUDAMEDFDA UDI
- Description
- Denture Acrylic HC Orig 1 lb P& L FDA UDI
Identifiers
- Catalog Number
- 1013061 FDA UDI
- Primary DI / UDI-DI
- ++H66810130611 EUDAMEDH66810130611 FDA UDI
- Basic UDI-DI
- B-++H66810130611 EUDAMED
- 510(k) Number
- K032773 FDA UDI
- FDA Product Code
- EBI FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3760 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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: Dental appliance fabrication material, resin
Diamond D by Keystone Industries — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — 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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- HI-I® — FRICKE INTERNATIONAL, INC. · Class II
- FREEPRINT crown A1 500g — DETAX GmbH · Class II
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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| 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 (2)
- FDA UDI 4a2b7a6b-8146-46f8-906d-84e459b577fb 37 fields · synced Jun 19, 2026
- EUDAMED 678e2b78-c8d7-475f-b478-ec8c43ec58cf 61 fields · synced Jun 19, 2026