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Starter Kit - Bands - Straight loop

FDA UDI

Class I (US FDA UDI)

by Nusmile, Ltd

Identity

Trade Name
Starter Kit - Bands (Straight loop, Curved loop, Distal shoe) FDA UDI
Generic Name
Orthodontic space maintainer FDA UDI
Device Name
Starter Kit - Bands (Straight loop, Curved loop, Distal shoe) FDA UDI
Model / Reference
UCSMSK FDA UDI
Description
Starter Kit - Bands (Straight loop, Curved loop, Distal shoe) FDA UDI

Identifiers

Primary DI / UDI-DI
00810118103568 FDA UDI
FDA Product Code
DYT FDA UDI
GMDN Term
Orthodontic space maintainer FDA UDI
Models / Variants
Straight loop FDA UDI
Curved loop FDA UDI
Distal shoe FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.5525 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

Yes

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthodontic space maintainer

Starter Kit - Bands - Straight loop by Nusmile, Ltd — Class I — FDA UDI — listed in FDA GUDID — 3 models — 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
Nusmile, Ltd

Sources (1)

  • FDA UDI 168cd4c6-028c-4f5c-b146-02691427a9e9 34 fields · synced May 31, 2026