Identity
- Trade Name
- PALA cre-active, pink, 3 g FDA UDI
- Generic Name
- Dental appliance fabrication material, thermoplastic FDA UDI
- Device Name
- Material tooth shade resin FDA UDI
- Model / Reference
- 66033449 FDA UDI
- Description
- Material tooth shade resin FDA UDI
Identifiers
- Catalog Number
- 66033449 FDA UDI
- Primary DI / UDI-DI
- J014660334490 FDA UDI
- 510(k) Number
- K914456 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental appliance fabrication material, thermoplastic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 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
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: Dental appliance fabrication material, thermoplastic
PALA cre-active, pink, 3 g by Kulzer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental appliance fabrication material, thermoplastic.
- Proform — Keystone Industries · U
- G-CAM — GRAPHENANO DENTAL SL. · Class II
- G-CAM — GRAPHENANO DENTAL SL. · Class II
- Vertex-Dental BV — Vertex-Dental B.V. · Class II
- FlexiNylon cartridges Natural — Perflex · Class II
- G-CAM — GRAPHENANO DENTAL SL. · Class II
- G-CAM — GRAPHENANO DENTAL SL. · Class II
- Clear Advantage — ORTHO TECHNOLOGY, INC. · Class I
Cleared under the same submission
K914456 also covers:
- PALA cre-active (assortment) — Kulzer, Inc.
- PALA cre-active, black, 3 g — Kulzer, Inc.
- PALA cre-active, gingiva, R 50, 3 g — Kulzer, Inc.
- PALA cre-active, gingiva, light pink, 3 — Kulzer, Inc.
- PALA cre-active, gingiva, pink 3 g — Kulzer, Inc.
- PALA cre-active, gingiva, shade 200, 3 g — Kulzer, Inc.
- PALA cre-active, gum, 3 g — Kulzer, Inc.
- PALA cre-active, maroon, 3 g — Kulzer, Inc.
- PALA cre-active, polar, 3 g — Kulzer, Inc.
- PALA cre-active, red, 3 g — Kulzer, Inc.
- PALA cre-active, white, 3 g — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kulzer, Inc.
Sources (1)
- FDA UDI b5611645-22fa-4723-be5e-e6f0650c16bb 36 fields · synced May 31, 2026