Identity
- Trade Name
- FLEXACRYL POWDER FDA UDI
- Generic Name
- Denture reliner, soft, professional FDA UDI
- Device Name
- DENTURE RELINE ACRYLIC RESIN POWDER FDA UDI
- Model / Reference
- 100 GRAMS FIBRED PINK FDA UDI
- Description
- DENTURE RELINE ACRYLIC RESIN POWDER FDA UDI
Identifiers
- Catalog Number
- 0920FIB FDA UDI
- Primary DI / UDI-DI
- D6500920FIB0 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Denture reliner, soft, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Denture reliner, soft, professional
Flexacryl Powder by Lang Dental Manufacturing Company, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Denture reliner, soft, professional.
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- Hydro-Cast® — Sultan Healthcare Inc · Class II
- SUPER-SOFT™ — Gc America Inc. · Class II
- Chairside — Zest Anchors, LLC · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Lang Dental Manufacturing Company, Inc.
Sources (2)
- FDA UDI f34eb806-4702-45d6-bd9b-5e225a1532f2 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026