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Venus Bulk Fill Syringe Intro Kit A3+TE
FDA UDIClass II (US FDA UDI)
by Kulzer, Inc.
Identity
- Trade Name
- Venus Bulk Fill Syringe Intro Kit A3+TE FDA UDI
- Generic Name
- Dental cavity varnish FDA UDI
- Device Name
- Varnish, cavity FDA UDI
- Model / Reference
- 66046794 FDA UDI
- Description
- Varnish, cavity FDA UDI
Identifiers
- Catalog Number
- 66046794 FDA UDI
- Primary DI / UDI-DI
- J014660467940 FDA UDI
- 510(k) Number
- K091635 FDA UDI
- FDA Product Code
- LBH FDA UDI
- GMDN Term
- Dental cavity varnish FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3260 FDA UDI
- Commercial Distribution
- Not 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
Venus Bulk Fill Syringe Intro Kit A3+TE by Kulzer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K091635 also covers:
- VENUS Diamond FLOW — Kulzer, Inc.
- VENUS Diamond FLOW — Kulzer, Inc.
- VENUS Diamond FLOW — Kulzer, Inc.
- VENUS Diamond FLOW — Kulzer, Inc.
- VENUS Diamond FLOW — Kulzer, Inc.
- VENUS Diamond FLOW — Kulzer, Inc.
- VENUS Diamond FLOW — Kulzer, Inc.
- VENUS Diamond FLOW — Kulzer, Inc.
- VENUS Diamond FLOW — Kulzer, Inc.
- VENUS Diamond FLOW PLT 20x0, 20G - Base — Kulzer, Inc.
- VENUS Diamond FLOW PLT 20x0, 20G - CL — Kulzer, Inc.
- VENUS Diamond FLOW PLT 20x0, 20g - A1 — 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 79700602-78d5-4a62-8361-be6dad6f2ba1 37 fields · synced Jun 1, 2026