TruContact

FDA UDI

Class I (US FDA UDI)

by Bioclear Matrix Systems, LLC

Identity

Trade Name: TruContact FDA UDI
Generic Name: Dental abrasive strip, reusable FDA UDI
Device Name: Strip with a handle that is used to break and lighten a contact between teeth to ease placement of matrix for dental restoration. FDA UDI
Model / Reference: Blue FDA UDI
Description: Strip with a handle that is used to break and lighten a contact between teeth to ease placement of matrix for dental restoration. FDA UDI

Identifiers

Primary DI / UDI-DI: D94961303181 FDA UDI
FDA Product Code: DZP FDA UDI
GMDN Term: Dental abrasive strip, reusable 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental abrasive strip, reusable

TruContact by Bioclear Matrix Systems, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental abrasive strip, reusable.

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KOMET Diamond Strip, Polishing Strip — Gebr. Brasseler GmbH & Co. KG · Class I
Two Striper — ABRASIVE TECHNOLOGY, LLC · Class I
SB-60HR — GNI Co., Ltd · Class I
Henry Schein — HENRY SCHEIN, INC. · Class I
SB-15HD — GNI Co., Ltd · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Bioclear Matrix Systems, LLC

Sources (1)

FDA UDI b8a0edc4-748f-4089-9094-0046800f0e4d 33 fields · synced Jun 6, 2026