Sunshine Diamonds

FDA UDI

Class I (US FDA UDI)

by Dr. Hopf GmbH & Co. KG

Identity

Trade Name: Sunshine Diamonds FDA UDI
Generic Name: Dental abrasive strip, single-use FDA UDI
Device Name: Separating strips FDA UDI
Model / Reference: 366D FDA UDI
Description: Separating strips FDA UDI

Identifiers

Primary DI / UDI-DI: ESUN366D8 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

Sunshine Diamonds by Dr. Hopf GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental abrasive strip, single-use.

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STEEL ABRASIVE STRIPS, 6 mm, double side coated, medium grits — Produits dentaires S.A. · Class I
Horico — Hopf, Ringleb & Co. GmbH & Cie. · Class I
Horico — Hopf, Ringleb & Co. GmbH & Cie. · Class I
Horico — Hopf, Ringleb & Co. GmbH & Cie. · Class I
ContacEZ — Directa AB · Class I
FitStrip™ — GARRISON DENTAL SOLUTIONS, L.L.C. · 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: Dr. Hopf GmbH & Co. KG

Sources (1)

FDA UDI 2a3abfce-7647-4712-a252-55e6bf513b81 33 fields · synced Jun 1, 2026