DENTCA Tray

FDA UDI

Class I (US FDA UDI)

by Dentca, Inc.

Identity

Trade Name: DENTCA Tray FDA UDI
Generic Name: Dental impression tray, single-use FDA UDI
Device Name: Lip Ruler FDA UDI
Model / Reference: DENTCA Lip Ruler FDA UDI
Description: Lip Ruler FDA UDI

Identifiers

Primary DI / UDI-DI: 00856551007100 FDA UDI
FDA Product Code: EHY FDA UDI
GMDN Term: Dental impression tray, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6880 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental impression tray, single-use

DENTCA Tray by Dentca, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental impression tray, single-use.

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COE® — Gc America Inc. · Class I
Plasdent — PLASDENT CORP. · Class I
EXCELLENT — PLASDENT CORP. · Class I
IMPRESSION TRAYS PERFORATED FULL DENTURE UPPER XL U4 — Daddy D Pro · Class I
Ador-Löffelplatten — dent a pharm Produktionsgesellschaft mbH · Class I
BENCO — BENCO DENTAL SUPPLY CO. · Class I
Zap Dual Arch Flouride Gel Trays — CROSSTEX INTERNATIONAL, INC. · 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: Dentca, Inc.

Sources (1)

FDA UDI ac3236c3-16f8-46ad-a88c-489c7e8d4bdc 34 fields · synced Jun 8, 2026