Identity
- Trade Name
- JUVORA Dental Disc, Ceramill PEEK by JUVORA FDA UDI
- Generic Name
- Dental bridge, polymer FDA UDI
- Device Name
- CARES® 16-unit restoration, JUVORA(TM) PEEK FDA UDI
- Model / Reference
- Bridges (tooth borne) FDA UDI
- Description
- CARES® 16-unit restoration, JUVORA(TM) PEEK FDA UDI
Identifiers
- Catalog Number
- 010.4136 FDA UDI
- Primary DI / UDI-DI
- 07630031739735 FDA UDI
- 510(k) Number
- K160918 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Dental bridge, 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental bridge, 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 Dental bridge, polymer.
- Try-In I — Zirkonzahn GmbH · Class II
- Abro Basic Multistratum A2-A3 125H10 — Zirkonzahn GmbH · Class II
- Abro Basic Mono C2-C3 98H18 — Zirkonzahn GmbH · Class II
- Abro Basic Mono B2-B3 98H14 — Zirkonzahn GmbH · Class II
- Try-In I — Zirkonzahn GmbH · Class II
- Temp Premium Flexible — Zirkonzahn GmbH · Class II
- Abro Basic Mono A2 125H15 — Zirkonzahn GmbH · Class II
- Abro Basic Mono A2-A3 95H27 — Zirkonzahn GmbH · Class II
Cleared under the same submission
K160918 also covers:
- JUVORA Dental Disc, Ceramill PEEK by JUVORA — Institut Straumann SA
- JUVORA Dental Disc, Ceramill PEEK by JUVORA — Institut Straumann SA
- JUVORA Dental Disc, Ceramill PEEK by JUVORA — Institut Straumann SA
- JUVORA Dental Disc, Ceramill PEEK by JUVORA — Institut Straumann SA
- JUVORA Dental Disc, Ceramill PEEK by JUVORA — Institut Straumann SA
- JUVORA Dental Disc, Ceramill PEEK by JUVORA — Institut Straumann SA
- JUVORA Dental Disc, Ceramill PEEK by JUVORA — Institut Straumann SA
- JUVORA Dental Disc, Ceramill PEEK by JUVORA — Institut Straumann SA
- JUVORA Dental Disc, Ceramill PEEK by JUVORA — Institut Straumann SA
- JUVORA Dental Disc, Ceramill PEEK by JUVORA — Institut Straumann SA
- JUVORA Dental Disc, Ceramill PEEK by JUVORA — Institut Straumann SA
- JUVORA Dental Disc, Ceramill PEEK by JUVORA — Institut Straumann SA
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Institut Straumann SA
Sources (1)
- FDA UDI bcd1a9c4-029b-4a89-a7c7-37194bafeb6c 36 fields · synced May 30, 2026