Identity
- Trade Name
- FIRST QUARTER FDA UDI
- Generic Name
- Polyether dental impression material FDA UDI
- Device Name
- IST QTR,FS, LT.BODY,4 PACK FDA UDI
- Model / Reference
- 89272 FDA UDI
- Description
- IST QTR,FS, LT.BODY,4 PACK FDA UDI
Identifiers
- Catalog Number
- 89272 FDA UDI
- Primary DI / UDI-DI
- 00816594021112 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Polyether dental impression material
First Quarter by Danville Materials, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyether dental impression material.
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- Ramitec™ — 3M Deutschland GmbH · Class I
- Impregum™ Penta™ Soft Medium Body — 3M Deutschland GmbH · Class II
- Impregum™ Penta™ — 3M Deutschland GmbH · Class II
- Impregum™ F — 3M Deutschland GmbH · Class II
- FLEXITIME DYNAMIX HT REFILL 1X(2X380ml) — Kulzer, Inc. · Class II
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
- Danville Materials, Llc
Sources (1)
- FDA UDI 51238574-53cd-4681-b49d-7785667f411a 36 fields · synced May 30, 2026