Identity
- Trade Name
- BD Impress FDA UDI
- Generic Name
- Composite dental impression material FDA UDI
- Device Name
- Thermoplastic pellets softens within dip hot water for bite registrations,Anterior bite stops,,Custom impression material,Customs impression tray,Bleaching trays,Build walls of impressions,Orthopedic appliances. Color White 200gr. net jar FDA UDI
- Model / Reference
- White 200gr. FDA UDI
- Description
- Thermoplastic pellets softens within dip hot water for bite registrations,Anterior bite stops,,Custom impression material,Customs impression tray,Bleaching trays,Build walls of impressions,Orthopedic appliances. Color White 200gr. net jar FDA UDI
Identifiers
- Catalog Number
- 1032126 FDA UDI
- Primary DI / UDI-DI
- 07290110501969 FDA UDI
- FDA Product Code
- EBH FDA UDI
- GMDN Term
- Composite dental impression material FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3670 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Composite dental impression material
BD Impress by Perflex — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Composite dental impression material.
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- UltraSil Putty 1000 — Dsi Dental Solutions, Ltd. · Class II
- Accusil Monophase — PREVEST DENPRO LIMITED · Class II
- Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class II
- Bosworth Superbite — Harry J. Bosworth Co. · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Perflex
Sources (1)
- FDA UDI 6e6d028c-2755-46f0-9bb6-b0ea0898960c 35 fields · synced Jun 6, 2026