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Smilegoods Aligner Chewies Assorted

FDA UDI

Class I (US FDA UDI)

by Practicon, Inc.

Identity

Trade Name
SMILEGOODS ALIGNER CHEWIES ASSORTED FDA UDI
Generic Name
Orthodontic aligner/retainer seater, single-use FDA UDI
Device Name
Silicone tube used to help seat a clear aligner by biting down on the device. 120 per pack FDA UDI
Model / Reference
71098134 AST FDA UDI
Description
Silicone tube used to help seat a clear aligner by biting down on the device. 120 per pack FDA UDI

Identifiers

Catalog Number
71098134 AST FDA UDI
Primary DI / UDI-DI
00723896026908 FDA UDI
FDA Product Code
ECQ 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

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

Smilegoods Aligner Chewies Assorted by Practicon, 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
Practicon, Inc.

Sources (1)

  • FDA UDI 9b39f91a-6e7c-434e-977a-7afc8e589145 34 fields · synced Jun 8, 2026