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VENUS DIAMOND PLT REF.2x10x0, 25G HKA2, 5
FDA UDIClass II (US FDA UDI)
by Kulzer, Inc.
Identity
- Trade Name
- VENUS DIAMOND PLT REF.2x10x0,25G HKA2,5 FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Dental Composite resin FDA UDI
- Model / Reference
- 66039010 FDA UDI
- Description
- Dental Composite resin FDA UDI
Identifiers
- Catalog Number
- 66039010 FDA UDI
- Primary DI / UDI-DI
- J014660390100 FDA UDI
- 510(k) Number
- K073554 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental composite resin
VENUS DIAMOND PLT REF.2x10x0, 25G HKA2, 5 by Kulzer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental composite resin.
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- SimpliShade — KERR CORPORATION · Class II
- Bright Flow Core DC 5ml Dentine — DMP Dental Industry S.A. · Class IIa
- Llis — Dentscare Ltda · Class II
- Capo Universal, 6 g — Schütz Dental GmbH · Class II
- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
Cleared under the same submission
K073554 also covers:
- VENUS DIAMOND PLT REFILL 1x10x0, 25G A4 — Kulzer, Inc.
- VENUS DIAMOND PLT REFILL 1x10x0, 25G AM — Kulzer, Inc.
- VENUS DIAMOND PLT REFILL 1x10x0, 25G B3 — Kulzer, Inc.
- VENUS DIAMOND PLT REFILL 1x10x0, 25G BL — Kulzer, Inc.
- VENUS DIAMOND PLT REFILL 1x10x0, 25G BXL — Kulzer, Inc.
- VENUS DIAMOND PLT REFILL 1x10x0, 25G C3 — Kulzer, Inc.
- VENUS DIAMOND PLT REFILL 1x10x0, 25G CL — Kulzer, Inc.
- VENUS DIAMOND PLT REFILL 1x10x0, 25G CO — Kulzer, Inc.
- VENUS DIAMOND PLT REFILL 1x10x0, 25G D3 — Kulzer, Inc.
- VENUS DIAMOND PLT REFILL 1x10x0, 25G HKA5 — Kulzer, Inc.
- VENUS DIAMOND PLT REFILL 1x10x0, 25G OB — Kulzer, Inc.
- VENUS DIAMOND PLT REFILL 1x10x0, 25G ODC — Kulzer, Inc.
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
- Kulzer, Inc.
Sources (1)
- FDA UDI 6ca9b203-7827-430b-b6ea-c92001b7d924 36 fields · synced May 31, 2026