Horico

FDA UDI

Class I (US FDA UDI)

by Hopf, Ringleb & Co. GmbH & Cie.

Identity

Trade Name: Horico FDA UDI
Generic Name: Dental abrasive strip, single-use FDA UDI
Device Name: Separating strip FDA UDI
Model / Reference: C343 FDA UDI
Description: Separating strip FDA UDI

Identifiers

Primary DI / UDI-DI: EHORC3438 FDA UDI
FDA Product Code: EHM FDA UDI
GMDN Term: Dental abrasive strip, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6010 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

Yes

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental abrasive strip, single-use

Horico by Hopf, Ringleb & Co. GmbH & Cie. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental abrasive strip, single-use.

Sunshine Diamonds — Dr. Hopf GmbH & Co. KG · Class I
Microdont — 3R - INDUSTRIA E COMERCIO EIRELI · Class I
STEEL ABRASIVE STRIPS, 6 mm, double side coated, medium grits — Produits dentaires S.A. · Class I
ContacEZ — Directa AB · Class I
FitStrip™ — GARRISON DENTAL SOLUTIONS, L.L.C. · Class I
Microdont — 3R - INDUSTRIA E COMERCIO EIRELI · Class I
Sunshine Diamonds — Dr. Hopf GmbH & Co. KG · Class I
Sunshine Diamonds — Dr. Hopf GmbH & Co. KG · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Hopf, Ringleb & Co. GmbH & Cie.

Sources (1)

FDA UDI fc115fcc-90e6-467f-955c-9f735428dfdb 33 fields · synced May 30, 2026