Identity
- Trade Name
- Amtouch Aligner Chewies FDA UDI
- Generic Name
- Orthodontic aligner/retainer seater, single-use FDA UDI
- Device Name
- Aligner Chewies - Unscented - White (20/pk) FDA UDI
- Model / Reference
- Unscented - White FDA UDI
- Description
- Aligner Chewies - Unscented - White (20/pk) FDA UDI
Identifiers
- Catalog Number
- AMAC-WH FDA UDI
- Primary DI / UDI-DI
- 00850058951379 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthodontic aligner/retainer seater, single-use
Amtouch Aligner Chewies by American Medical & Hospital Supply Co., Inc. — 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
- Plasdent — PLASDENT CORP. · 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
- 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
- American Medical & Hospital Supply Co., Inc.
Sources (1)
- FDA UDI 2291b4e5-1200-4344-9ca1-6f47b8391e87 34 fields · synced May 30, 2026