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JUVORA™ Dental Disc

FDA UDI

Class II (US FDA UDI)

by Juvora

Identity

Trade Name
JUVORA™ Dental Disc FDA UDI
Generic Name
Dental appliance fabrication material, thermoplastic FDA UDI
Device Name
JUVORA™ Dental Disc, 540019, US-DD-98-22-01 FDA UDI
Model / Reference
540019 FDA UDI
Description
JUVORA™ Dental Disc, 540019, US-DD-98-22-01 FDA UDI

Identifiers

Primary DI / UDI-DI
05055948200390 FDA UDI
510(k) Number
K132725 FDA UDI
K160918 FDA UDI
FDA Product Code
EBI FDA UDI
EBG FDA UDI
EBF FDA UDI
GMDN Term
Dental appliance fabrication material, thermoplastic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3760 FDA UDI
872.3770 FDA UDI
872.3690 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Height — 22 Millimeter FDA UDI
Outer Diameter — 98 Millimeter FDA UDI

JUVORA™ Dental Disc by Juvora — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K160918 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Juvora

Sources (1)

  • FDA UDI 4ba974f7-87fa-4cb4-8add-226a4744c37b 37 fields · synced May 30, 2026