Identity
- Trade Name
- Permlastic FDA UDI
- Generic Name
- Polysulfide dental impression material FDA UDI
- Device Name
- Impression material base, regular bodied FDA UDI
- Model / Reference
- 00493 FDA UDI
- Description
- Impression material base, regular bodied FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841396118630 FDA UDI
- 510(k) Number
- K003650 FDA UDI
- FDA Product Code
- ELW FDA UDI
- GMDN Term
- Polysulfide 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
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 100 Gram FDA UDI
Category: Polysulfide dental impression material
Permlastic by Kerr Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polysulfide dental impression material.
- Vivid Image 380 cartridge monophase — PEARSON DENTAL SUPPLIES, INC. · Class II
- Vivid Alginate Substitute Std Pkg — PEARSON DENTAL SUPPLIES, INC. · Class II
- Vivid Flavor Match Berry Regular Set Heavy — PEARSON DENTAL SUPPLIES, INC. · Class II
- Vivid Image Monophase Fast Set — PEARSON DENTAL SUPPLIES, INC. · Class II
- Vivid Image Light Body Regular Set — PEARSON DENTAL SUPPLIES, INC. · Class II
- Vivid Image Tubes Light Body — PEARSON DENTAL SUPPLIES, INC. · Class II
- Vivid Flavor Match Vanilla Fast Set Light — PEARSON DENTAL SUPPLIES, INC. · Class II
- Vvid Supreme Bite Blue — PEARSON DENTAL SUPPLIES, INC. · Class II
Cleared under the same submission
K003650 also covers:
- Permlastic — KERR CORPORATION
- Permlastic — KERR CORPORATION
- Permlastic — KERR CORPORATION
- Permlastic — KERR CORPORATION
- Permlastic — KERR CORPORATION
- Permlastic — KERR CORPORATION
- Permlastic — KERR CORPORATION
- Permlastic — KERR CORPORATION
- Permlastic — KERR CORPORATION
- Permlastic — KERR CORPORATION
- Permlastic — KERR CORPORATION
- Rubber Base Adhesive — KERR CORPORATION
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kerr Corporation
Sources (1)
- FDA UDI 5aca3c7d-0338-4ea5-8883-c52d32e9b913 37 fields · synced Jun 8, 2026