Identity
- Trade Name
- Smile Stretcher FDA UDI
- Generic Name
- Dental cheek retractor, home-use FDA UDI
- Device Name
- Device to retract the lips/cheeks to facilitate viewing of the teeth. FDA UDI
- Model / Reference
- BSS1 FDA UDI
- Description
- Device to retract the lips/cheeks to facilitate viewing of the teeth. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850017524002 FDA UDI
- FDA Product Code
- EIF FDA UDI
- GMDN Term
- Dental cheek retractor, home-use 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
Category: Dental cheek retractor, home-use
Smile Stretcher by Straight Smile Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental cheek retractor, home-use.
- ScanBox pro - Candid — Dental Monitoring · Class I
- ScanBox pro - Candid — Dental Monitoring · Class I
- ScanBox pro - Smile Doctors — Dental Monitoring · Class I
- ScanBox pro - Candid — Dental Monitoring · Class I
- Smile stretcher-purple bag — Access Dental Lab, LLC · Class I
- ScanBox pro Smile Doctors — Dental Monitoring · Class I
- Scanbox pro - Smile Doctors — Dental Monitoring · Class I
- ScanBox pro Smile doctors — Dental Monitoring · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Straight Smile Llc
Sources (1)
- FDA UDI f24c7af8-08bd-43c4-b8b8-9dbb3fb81120 33 fields · synced May 30, 2026