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Chewies

FDA UDI

Class I (US FDA UDI)

by Dentsply Sirona Orthodontics Inc.

Identity

Trade Name
Chewies FDA UDI
Generic Name
Orthodontic aligner/retainer seater, single-use FDA UDI
Device Name
Chewies ™ Aligner Tray Seaters – 2pk White FDA UDI
Model / Reference
BCHW1 FDA UDI
Description
Chewies ™ Aligner Tray Seaters – 2pk White FDA UDI

Identifiers

Catalog Number
BCHW1 FDA UDI
Primary DI / UDI-DI
D746BCHW11 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthodontic aligner/retainer seater, single-use

Chewies by Dentsply Sirona Orthodontics Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic aligner/retainer seater, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dentsply Sirona Orthodontics Inc.

Sources (1)

  • FDA UDI c2138dc3-6d81-4852-bab0-6a1f4961127f 35 fields · synced Jun 9, 2026