JUVORA Dental Disc, Ceramill PEEK by JUVORA

FDA UDI

Class II (US FDA UDI)

by Institut Straumann SA

Identity

Trade Name: JUVORA Dental Disc, Ceramill PEEK by JUVORA FDA UDI
Generic Name: Custom-made dental crown, polymer FDA UDI
Device Name: CARES® single-unit restoration, JUVORA(TM) PEEK FDA UDI
Model / Reference: Crowns FDA UDI
Description: CARES® single-unit restoration, JUVORA(TM) PEEK FDA UDI

Identifiers

Catalog Number: 010.4121 FDA UDI
Primary DI / UDI-DI: 07630031739582 FDA UDI
510(k) Number: K160918 FDA UDI
FDA Product Code: EBI FDA UDI
GMDN Term: Custom-made dental crown, polymer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3760 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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Custom-made dental crown, polymer

JUVORA Dental Disc, Ceramill PEEK by JUVORA by Institut Straumann SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Custom-made dental crown, polymer.

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PMMA CAD/CAM Disc — POLIDENT d.o.o. · Class II
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PMMA CAD/CAM Disc — POLIDENT d.o.o. · Class II
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Flexcera™ Smile Ultra+ Bleach — Envisiontec GmbH · Class II
PMMA CAD/CAM Disc — POLIDENT d.o.o. · Class II
PMMA CAD/CAM Disc — POLIDENT d.o.o. · Class II

Cleared under the same submission

K160918 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Institut Straumann SA

Sources (1)

FDA UDI f2933b94-649d-47a2-8610-9feae634bf71 36 fields · synced May 30, 2026