Identity
- Trade Name
- Plasdent FDA UDI
- Generic Name
- Orthodontic aligner/retainer seater, single-use FDA UDI
- Device Name
- Aligner Tray Seaters, Assorted FDA UDI
- Model / Reference
- ATS-A FDA UDI
- Description
- Aligner Tray Seaters, Assorted FDA UDI
Identifiers
- Catalog Number
- ATS-A FDA UDI
- Primary DI / UDI-DI
- D832ATSA1 FDA UDI
- FDA Product Code
- NRD FDA UDI
- GMDN Term
- Orthodontic aligner/retainer seater, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6640 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
Plasdent by Plasdent Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic aligner/retainer seater, single-use.
- ORTHOCHEWIE — ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA · Class I
- Young Specialties — Young Innovations, Inc. · Class I
- Chewies — ORTHO TECHNOLOGY, INC. · Class I
- SMILEGOODS ALIGNER CHEWIES ASSORTED 24 PACK — PRACTICON, INC. · Class I
- SMILEGOODS ALIGNER CHEWIES UNSCENTED 24 PACK — PRACTICON, INC. · Class I
- ORTHO ALIGNER TRAY SEATERS — MAXILL, INC. · Class I
- Rodney — GC Orthodontics America Inc. · Class I
- SMILEGOODS ALIGNER CHEWIES UNSCENTED — PRACTICON, 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 I | Pending data |
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Manufacturer
- Manufacturer
- Plasdent Corp.
Sources (1)
- FDA UDI 762e99db-396d-4f9c-aa68-c1c40435da5f 34 fields · synced May 30, 2026