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Diamond D Ultra Impact Denture Acrylic
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1013015Ref 1013071Ref 1013028Ref 1013062Ref 1013105Ref 1013112Ref 1013069Ref 1013070Ref 1013039Ref 1013034Ref 1013025Ref 1013029Ref 1013021Ref 1013022Ref 1013033Ref 1013114Ref 1013065Ref 1013113
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 Dk Veined 5 lb P&L FDA UDIDenture Acryic HC Chroma Ess FDA UDIDenture Acrylic HC Orig Pwd FDA UDIDenture Acrylic HC Light Pwd FDA UDIDenture Acrylic HC Dk Veined 1 lb P&L FDA UDIDenture Acrylic HC Dk Veined FDA UDIDenture Acryic HC Chroma Ess pwd FDA UDIDenture Acrylic HC Light 25 lb P&L FDA UDIDenture Acrylic HC Original Pwd 150 g FDA UDIDenture Acrylic HC Orig 5 lb P&L FDA UDIDenture Acrylic HC Orig 25 lb P&L FDA UDIDenture Acrylic HC Lrp 25 lb P& L FDA UDIDenture Acrylic HC Light 1 lb P& L FDA UDIDenture Acrylic HC Liquid FDA UDIDenture Acrylic HC Lrp pwd FDA UDIDenture Acrylic HC Dk Veined 25 lb P&L FDA UDI
- Model / Reference
- 1013015 EUDAMEDFDA UDI1013113 EUDAMEDFDA UDI1013034 EUDAMEDFDA UDI1013022 EUDAMEDFDA UDI1013025 EUDAMEDFDA UDI1013112 EUDAMEDFDA UDI1013105 EUDAMEDFDA UDI1013033 EUDAMEDFDA UDI1013070 EUDAMEDFDA UDI1013039 EUDAMEDFDA UDI1013065 EUDAMEDFDA UDI1013021 EUDAMEDFDA UDI1013069 EUDAMEDFDA UDI1013071 EUDAMEDFDA UDI1013062 EUDAMEDFDA UDI1013028 EUDAMEDFDA UDI1013029 EUDAMEDFDA UDI1013114 EUDAMEDFDA UDI
- Description
- Denture Acrylic HC Dk Veined 5 lb P&L FDA UDIDenture Acryic HC Chroma Ess FDA UDIDenture Acrylic HC Orig Pwd FDA UDIDenture Acrylic HC Light Pwd FDA UDIDenture Acrylic HC Dk Veined 1 lb P&L FDA UDIDenture Acrylic HC Dk Veined FDA UDIDenture Acryic HC Chroma Ess pwd FDA UDIDenture Acrylic HC Light 25 lb P&L FDA UDIDenture Acrylic HC Original Pwd 150 g FDA UDIDenture Acrylic HC Orig 5 lb P&L FDA UDIDenture Acrylic HC Orig 25 lb P&L FDA UDIDenture Acrylic HC Lrp 25 lb P& L FDA UDIDenture Acrylic HC Light 1 lb P& L FDA UDIDenture Acrylic HC Liquid FDA UDIDenture Acrylic HC Lrp pwd FDA UDIDenture Acrylic HC Dk Veined 25 lb P&L FDA UDI
Identifiers
- Catalog Number
- 1013113 FDA UDI1013034 FDA UDI1013022 FDA UDI1013025 FDA UDI1013112 FDA UDI1013105 FDA UDI1013033 FDA UDI1013070 FDA UDI1013039 FDA UDI1013065 FDA UDI1013021 FDA UDI1013069 FDA UDI1013071 FDA UDI1013062 FDA UDI1013015 FDA UDI1013028 FDA UDI1013029 FDA UDI1013114 FDA UDI
- Primary DI / UDI-DI
- H66810130151 EUDAMEDFDA UDI++H66810130711 EUDAMED++H66810130281 EUDAMED++H66810130621 EUDAMED++H66810131051 EUDAMED++H66810131121 EUDAMED++H66810130691 EUDAMED++H66810130701 EUDAMED++H66810130391 EUDAMED++H66810130341 EUDAMED++H66810130251 EUDAMED++H66810130291 EUDAMED++H66810130211 EUDAMED++H66810130221 EUDAMED++H66810130331 EUDAMED++H66810131141 EUDAMED++H66810130651 EUDAMED++H66810131131 EUDAMEDH66810131131 FDA UDIH66810130341 FDA UDIH66810130221 FDA UDIH66810130251 FDA UDIH66810131121 FDA UDIH66810131051 FDA UDIH66810130331 FDA UDIH66810130701 FDA UDIH66810130391 FDA UDIH66810130651 FDA UDIH66810130211 FDA UDIH66810130691 FDA UDIH66810130711 FDA UDIH66810130621 FDA UDIH66810130281 FDA UDIH66810130291 FDA UDIH66810131141 FDA UDI
- Basic UDI-DI
- B-H66810130151 EUDAMEDB-++H66810130711 EUDAMEDB-++H66810130281 EUDAMEDB-++H66810130621 EUDAMEDB-++H66810131051 EUDAMEDB-++H66810131121 EUDAMEDB-++H66810130691 EUDAMEDB-++H66810130701 EUDAMEDB-++H66810130391 EUDAMEDB-++H66810130341 EUDAMEDB-++H66810130251 EUDAMEDB-++H66810130291 EUDAMEDB-++H66810130211 EUDAMEDB-++H66810130221 EUDAMEDB-++H66810130331 EUDAMEDB-++H66810131141 EUDAMEDB-++H66810130651 EUDAMEDB-++H66810131131 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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 UDIFDA 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 UDIWeight — 2.27 Kilogram FDA UDIWeight — 5 Pound FDA UDIWeight — 1 Pound FDA UDIWeight — 0.45 Kilogram FDA UDIWeight — 150 Gram FDA UDITotal Volume — 0.95 Liter FDA UDITotal Volume — 1 Quart FDA UDI
Diamond D Ultra Impact Denture Acrylic by Keystone Industries — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-H66810130151 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Keystone Industries
- EUDAMED SRN
- US-MF-000020203
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (36)
- EUDAMED 5669c99e-8a17-4b02-9c31-d2d7657f7e5f 61 fields · synced Aug 3, 2026
- FDA UDI 12e44d61-8fdc-4811-b200-1b854c5c51c8 37 fields · synced May 29, 2026
- FDA UDI b2c7bc51-896e-4072-8ce9-d47703295802 37 fields · synced May 29, 2026
- FDA UDI 7788a92b-8f7e-4ffa-8d5a-27ec7503ecb7 37 fields · synced May 29, 2026
- FDA UDI 8479adb5-501a-4e18-af90-2484badb5ce8 37 fields · synced May 29, 2026
- FDA UDI 575221da-e22b-451a-9852-c267afe43285 37 fields · synced May 29, 2026
- FDA UDI ba676207-83d7-47fc-b5e1-944b53f24fd0 37 fields · synced May 30, 2026
- FDA UDI 8a87c630-5da2-42cd-bacf-0fbb2629787d 37 fields · synced May 30, 2026
- FDA UDI 6affeeb1-7f6b-4935-8c0b-cb5a8d16480f 37 fields · synced May 30, 2026
- FDA UDI b900df76-e2d9-4688-8468-9503ee47d9d8 38 fields · synced May 30, 2026
- FDA UDI 9dcbabf5-0708-4c29-8175-8a408b0cd874 37 fields · synced May 30, 2026
- FDA UDI 13a70868-abca-46e9-809a-a1cae47e4211 37 fields · synced May 30, 2026
- FDA UDI 8702fa4f-8e95-4142-9a49-16812a0f184a 37 fields · synced May 30, 2026
- FDA UDI 30ee04af-617e-4a85-8030-54b06159a488 37 fields · synced May 30, 2026
- FDA UDI a0af642d-e3d1-473f-a809-cfb1aca1a9f3 37 fields · synced May 30, 2026
- FDA UDI c6f4f56b-c708-4258-a993-77e965f6b432 38 fields · synced May 30, 2026
- FDA UDI efda41fe-8015-4e4d-abe1-dbf5bb84d55d 37 fields · synced May 30, 2026
- FDA UDI 3b08e351-a888-463a-a5fb-5f13ac4d958f 37 fields · synced May 30, 2026
- FDA UDI 15ceb973-0b33-49e9-87e4-bee2c3d60124 37 fields · synced May 30, 2026
- EUDAMED 8fe2045f-784f-4870-94c2-5bc0ae7755e6 61 fields · synced Jul 9, 2026
- EUDAMED dc987367-0cc3-4256-982b-3e97917315d0 61 fields · synced Jul 9, 2026
- EUDAMED 590ea20f-43f8-4a15-9958-7c5c0982d799 61 fields · synced Jul 10, 2026
- EUDAMED a2f7fce6-b587-4d4c-8fc9-a9cb58bd2034 61 fields · synced Jul 10, 2026
- EUDAMED ac5b9e1c-d94e-431b-8780-7d2ed1c45590 61 fields · synced Jul 11, 2026
- EUDAMED 5d2131d6-e0c9-4757-a23c-9411830d2f12 61 fields · synced Jul 11, 2026
- EUDAMED 04327660-0ca9-4551-a810-82361958d138 61 fields · synced Jul 17, 2026
- EUDAMED c1dbe8dc-6d3f-4fa3-920c-991055260c40 61 fields · synced Jul 18, 2026
- EUDAMED af716162-5e68-4b4b-9a2a-155b8dbe42f6 61 fields · synced Jul 18, 2026
- EUDAMED 81f577b4-83ed-4942-b9b5-7068dc8d8d1f 61 fields · synced Jul 19, 2026
- EUDAMED 0e25a501-4d48-4881-9095-5df76c7fae61 61 fields · synced Jul 20, 2026
- EUDAMED 65b19f4d-b194-4743-b043-935e97a0b9eb 61 fields · synced Jul 20, 2026
- EUDAMED f8f36aab-1104-4b2e-b5a1-a8c24d1f0ed1 61 fields · synced Jul 21, 2026
- EUDAMED d6588f89-d9a5-4115-b41f-22101eeb17c9 61 fields · synced Jul 31, 2026
- EUDAMED 20f71754-b8cc-4e51-b9ff-c6b08fe548d9 61 fields · synced Aug 2, 2026
- EUDAMED f9b5188d-f7d2-4f94-8d20-6c2ad8c267d8 61 fields · synced Aug 2, 2026
- EUDAMED 8c732346-ecb6-44de-8396-345901354273 61 fields · synced Aug 3, 2026