JUVORA Dental Disc, Ceramill PEEK by JUVORA 010.4121

GUDID 07630031739582

CARES® single-unit restoration, JUVORA(TM) PEEK

Institut Straumann AG

Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer
Primary Device ID07630031739582
NIH Device Record Keyf2933b94-649d-47a2-8610-9feae634bf71
Commercial Distribution StatusIn Commercial Distribution
Brand NameJUVORA Dental Disc, Ceramill PEEK by JUVORA
Version Model NumberCrowns
Catalog Number010.4121
Company DUNS483599259
Company NameInstitut Straumann AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107630031739582 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630031739582]

Moist Heat or Steam Sterilization


[07630031739582]

Moist Heat or Steam Sterilization


[07630031739582]

Moist Heat or Steam Sterilization


[07630031739582]

Moist Heat or Steam Sterilization


[07630031739582]

Moist Heat or Steam Sterilization


[07630031739582]

Moist Heat or Steam Sterilization


[07630031739582]

Moist Heat or Steam Sterilization


[07630031739582]

Moist Heat or Steam Sterilization


[07630031739582]

Moist Heat or Steam Sterilization


[07630031739582]

Moist Heat or Steam Sterilization


[07630031739582]

Moist Heat or Steam Sterilization


[07630031739582]

Moist Heat or Steam Sterilization


[07630031739582]

Moist Heat or Steam Sterilization


[07630031739582]

Moist Heat or Steam Sterilization


[07630031739582]

Moist Heat or Steam Sterilization


[07630031739582]

Moist Heat or Steam Sterilization


[07630031739582]

Moist Heat or Steam Sterilization


[07630031739582]

Moist Heat or Steam Sterilization


[07630031739582]

Moist Heat or Steam Sterilization


[07630031739582]

Moist Heat or Steam Sterilization


[07630031739582]

Moist Heat or Steam Sterilization


[07630031739582]

Moist Heat or Steam Sterilization


[07630031739582]

Moist Heat or Steam Sterilization


[07630031739582]

Moist Heat or Steam Sterilization


[07630031739582]

Moist Heat or Steam Sterilization


[07630031739582]

Moist Heat or Steam Sterilization


[07630031739582]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-03-10
Device Publish Date2019-08-23

On-Brand Devices [JUVORA Dental Disc, Ceramill PEEK by JUVORA]

07630031739582CARES® single-unit restoration, JUVORA(TM) PEEK
07630031739735CARES® 16-unit restoration, JUVORA(TM) PEEK
07630031739728CARES® 15-unit restoration, JUVORA(TM) PEEK
07630031739711CARES® 14-unit restoration, JUVORA(TM) PEEK
07630031739704CARES® 13-unit restoration, JUVORA(TM) PEEK
07630031739698CARES® 12-unit restoration, JUVORA(TM) PEEK
07630031739681CARES® 11-unit restoration, JUVORA(TM) PEEK
07630031739674CARES® 10-unit restoration, JUVORA(TM) PEEK
07630031739667CARES® 9-unit restoration, JUVORA(TM) PEEK
07630031739650CARES® 8-unit restoration, JUVORA(TM) PEEK
07630031739643CARES® 7-unit restoration, JUVORA(TM) PEEK
07630031739636CARES® 6-unit restoration, JUVORA(TM) PEEK
07630031739629CARES® 5-unit restoration, JUVORA(TM) PEEK
07630031739612CARES® 4-unit restoration, JUVORA(TM) PEEK
07630031739605CARES® 3-unit restoration, JUVORA(TM) PEEK
07630031739599CARES® 2-unit restoration, JUVORA(TM) PEEK

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.