Identity
- Trade Name
- SmileDirectClub Retainer FDA UDI
- Generic Name
- Orthodontic retainer FDA UDI
- Device Name
- SmileDirectClub Retainers consist of a clear plastic removable orthodontic appliance which are intended to hold the teeth in their current position. FDA UDI
- Model / Reference
- 140-0004 FDA UDI
- Description
- SmileDirectClub Retainers consist of a clear plastic removable orthodontic appliance which are intended to hold the teeth in their current position. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850007728427 FDA UDI
- GMDN Term
- Orthodontic retainer FDA UDI
Classification
- 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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthodontic retainer
SmileDirectClub Retainer by Access Dental Lab, LLC — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Access Dental Lab, LLC
Sources (1)
- FDA UDI 2c298366-a89b-4a28-8dcc-b0aacbea7e80 34 fields · synced Jun 8, 2026