Identity
- Trade Name
- LABTEC FDA UDI
- Generic Name
- Custom-made mouthguard FDA UDI
- Device Name
- DENTURE MATERIAL - ECONO KIT - PACKAGE 320 GRAMS POWDER/ 240 GRAMS LIQUID FDA UDI
- Model / Reference
- PLTELEK1 FDA UDI
- Description
- DENTURE MATERIAL - ECONO KIT - PACKAGE 320 GRAMS POWDER/ 240 GRAMS LIQUID FDA UDI
Identifiers
- Catalog Number
- PLTELEK1 FDA UDI
- Primary DI / UDI-DI
- D810PLTELEK11 FDA UDI
- 510(k) Number
- K874025 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Custom-made mouthguard 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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: Custom-made mouthguard
Labtec by Astron Dental — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Custom-made mouthguard.
- BENCO — BENCO DENTAL SUPPLY CO. · Class I
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- Dentek — DenTek Oral Care, Inc. · U
- PRO3DURE THERMEO Blank — Pro3Dure Medical · U
- PRO3DURE THERMEO Powder — Pro3Dure Medical · U
- BENCO — BENCO DENTAL SUPPLY CO. · Class I
- SleepRight — Splintek, Inc. · U
Cleared under the same submission
K874025 also covers:
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
- Astron Dental
Sources (1)
- FDA UDI 1b4de718-0711-47f9-8b50-2059e1ccf72b 36 fields · synced Jun 1, 2026