Identity
- Trade Name
- DENTECH FDA UDI
- Generic Name
- Mouth gag, non-adjustable FDA UDI
- Device Name
- Dry field Mouth Props #3 small(Set of 3 pcs) FDA UDI
- Model / Reference
- 50570001 FDA UDI
- Description
- Dry field Mouth Props #3 small(Set of 3 pcs) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560218668615 FDA UDI
- FDA Product Code
- EIF FDA UDI
- GMDN Term
- Mouth gag, non-adjustable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Mouth gag, non-adjustable
Dentech by Dentech Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mouth gag, non-adjustable.
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- Plasdent — PLASDENT CORP. · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- MOUTH PROP ADULT BITE BLOCK WITHOUT ATTACHMENT BEAUDRY STYLE — W.H. Holden, Inc. · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
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
- Dentech Corp.
Sources (1)
- FDA UDI 89298409-313f-4c59-b709-b44d72597709 33 fields · synced May 30, 2026