Identity
- Trade Name
- SmartGuard FDA UDI
- Generic Name
- Mouthguard, reusable FDA UDI
- Device Name
- Dental mouth guard for clenching and grinding teeth (bruxism) FDA UDI
- Model / Reference
- SGDG6 FDA UDI
- Description
- Dental mouth guard for clenching and grinding teeth (bruxism) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00866330000208 FDA UDI
- 510(k) Number
- K123161 FDA UDI
- FDA Product Code
- OBR FDA UDIMQC FDA UDI
- GMDN Term
- Mouthguard, reusable FDA UDI
Classification
- Device Class
- U 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
Yes
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: Mouthguard, reusable
SmartGuard by Smartguard Rx Inc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mouthguard, reusable.
- PMMA BLOCK — Huliang(Shanghai) Biotech Co., Ltd. · U
- PMMA BLOCK — SHANDONG HUGE DENTAL MATERIAL CORPORATION · U
- PMMA BLOCK — Huliang(Shanghai) Biotech Co., Ltd. · Class II
- Nylon Nightguard/Occlusal Appliance — SERENA SLEEP SOLUTIONS LLC · U
- PMMA BLOCK — SHANDONG HUGE DENTAL MATERIAL CORPORATION · U
- PMMA BLOCK — SHANDONG HUGE DENTAL MATERIAL CORPORATION · U
- PMMA BLOCK — Huliang(Shanghai) Biotech Co., Ltd. · U
- AESCULAP — AESCULAP, 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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Smartguard Rx Inc
Sources (1)
- FDA UDI cdd488ae-8dea-4fbf-94f7-343a80bbbbc7 35 fields · synced Jun 8, 2026