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Invisalign IPR Sub-Assembly

FDA UDI

Class I (US FDA UDI)

by Align Technology, Inc.

Identity

Trade Name
Invisalign IPR Sub-Assembly FDA UDI
Generic Name
Orthodontic space maintainer FDA UDI
Model / Reference
20191 FDA UDI

Identifiers

Primary DI / UDI-DI
00850042861349 FDA UDI
FDA Product Code
DZP FDA UDI
GMDN Term
Orthodontic space maintainer FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4535 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

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
High-level Disinfectant FDA UDI

Category: Orthodontic space maintainer

Invisalign IPR Sub-Assembly by Align Technology, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic space maintainer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Align Technology, Inc.

Sources (1)

  • FDA UDI fb487629-6059-41c7-a24b-15a208756013 32 fields · synced May 30, 2026