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Plak Smacker

FDA UDI

Class I (US FDA UDI)

by Young Innovations, Inc.

Identity

Trade Name
Plak Smacker FDA UDI
Generic Name
Orthodontic archwire/bracket ligature FDA UDI
Device Name
Patient Ties, White (1,012 ct) FDA UDI
Model / Reference
254-03113 FDA UDI
Description
Patient Ties, White (1,012 ct) FDA UDI

Identifiers

Catalog Number
254-03113 FDA UDI
Primary DI / UDI-DI
00840326419625 FDA UDI
FDA Product Code
ECI FDA UDI
GMDN Term
Orthodontic archwire/bracket ligature FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.5410 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

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

No

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 archwire/bracket ligature

The Plak Smacker device is a patient-tied orthodontic archwire/bracket ligature, designed for single-use replacement during orthodontic treatment. It securely tethers an orthodontic archwire to an orthodontic bracket or holds it in place within the archwire slot of an orthodontic bracket (or brace). This small single tie is intended for implantable use and is not implantable.

Similar devices

Also classified as Orthodontic archwire/bracket ligature.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Young Innovations, Inc.

Sources (1)

  • FDA UDI 43fc97b7-6271-4786-81f3-ab9895b48f57 35 fields · synced Jul 13, 2026