Identity
- Trade Name
- ORTHO ALIGNER TRAY SEATERS FDA UDI
- Generic Name
- Orthodontic aligner/retainer seater, single-use FDA UDI
- Model / Reference
- 6070540031 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D89260705400312 FDA UDI
- FDA Product Code
- ECS FDA UDI
- GMDN Term
- Orthodontic aligner/retainer seater, single-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
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic aligner/retainer seater, single-use
Ortho Aligner Tray Seaters by Maxill, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic aligner/retainer seater, single-use.
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- Chewies — ORTHO TECHNOLOGY, INC. · Class I
- SMILEGOODS ALIGNER CHEWIES ASSORTED 24 PACK — PRACTICON, INC. · Class I
- Plasdent — PLASDENT CORP. · Class I
- SMILEGOODS ALIGNER CHEWIES UNSCENTED 24 PACK — PRACTICON, INC. · Class I
- Plasdent — PLASDENT CORP. · 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
- Maxill, Inc.
Sources (1)
- FDA UDI edbcb90c-fcce-40ab-81a3-f073aa783502 32 fields · synced May 30, 2026