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Flexitime Medium Flow 1x50ml Sample
FDA UDIClass II (US FDA UDI)
by Kulzer, Inc.
Identity
- Trade Name
- FLEXITIME MEDIUM FLOW 1X50ML SAMPLE FDA UDI
- Generic Name
- Polyether dental impression material FDA UDI
- Device Name
- Material, Impression FDA UDI
- Model / Reference
- 66077378 FDA UDI
- Description
- Material, Impression FDA UDI
Identifiers
- Catalog Number
- 66077378 FDA UDI
- Primary DI / UDI-DI
- J014660773780 FDA UDI
- 510(k) Number
- K091494 FDA UDI
- FDA Product Code
- ELW FDA UDI
- GMDN Term
- Polyether dental impression material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3660 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Polyether dental impression material
Flexitime Medium Flow 1x50ml Sample by Kulzer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Polyether dental impression material.
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- Impregum™ F — 3M Deutschland GmbH · Class II
- ROYAL — DANVILLE MATERIALS, LLC · Class II
Cleared under the same submission
K091494 also covers:
- FLEXITIME DYNAMIX HEAVY & FLOW TRIAL KIT — Kulzer, Inc.
- FLEXITIME LIGHT FLOW 1 X (2 X 50 ML) — Kulzer, Inc.
- FLEXITIME LIGHT FLOW 1 X (2 X 50 ML) — Kulzer, Inc.
- FLEXITIME LIGHT FLOW 1X50ML SAMPLE — Kulzer, Inc.
- FLEXITIME MEDIUM FLOW 1 X (2 X 50 ML) — Kulzer, Inc.
- FLEXITIME MEDIUM FLOW 1 X (2 X 50 ML) — 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 b58d2096-0ff0-4597-bb15-d39218780cf2 36 fields · synced May 31, 2026