Identity
- Trade Name
- Inbrace Teeth Straightening System FDA UDI
- Generic Name
- Orthodontic appliance/positioning tray kit FDA UDI
- Model / Reference
- Standard Patient Kit FDA UDI
Identifiers
- Catalog Number
- 8101 FDA UDI
- Primary DI / UDI-DI
- 00850018135009 FDA UDI
- FDA Product Code
- PNN FDA UDI
- GMDN Term
- Orthodontic appliance/positioning tray kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5470 FDA UDI
- 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthodontic appliance/positioning tray kit
Inbrace Teeth Straightening System by Swift Health Systems Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic appliance/positioning tray kit.
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- Indirect Bond W/Hard Shell — FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC. · Class I
- InBrace Teeth Straightening System (Gen 2.0) — SWIFT HEALTH SYSTEMS INC. · Class II
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 |
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Manufacturer
- Manufacturer
- Swift Health Systems Inc.
Sources (1)
- FDA UDI 34db9cef-01ea-438f-a24c-dd47381cd5b3 33 fields · synced Jun 6, 2026