n!ce Glass Ceramic Blocks 010.5253

GUDID 07630031730954

n!ce® Onlay, XshadeX

Institut Straumann AG

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Primary Device ID07630031730954
NIH Device Record Key98a7a8d4-1759-4ad9-98b2-e6a666256c82
Commercial Distribution StatusIn Commercial Distribution
Brand Namen!ce Glass Ceramic Blocks
Version Model NumberInlays / Onlays
Catalog Number010.5253
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
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
GS107630031730954 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIHPOWDER, PORCELAIN

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

Moist Heat or Steam Sterilization


[07630031730954]

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 [n!ce Glass Ceramic Blocks]

07630031739766n!ce® C, LT A2 & LT A3, A14L
07630031739759n!ce® C, LT A3, A14L
07630031739742n!ce® C, LT A2, A14L
07630031738707n!ce® C, LT A3 & HT A3, C14
07630031738691n!ce® C, LT A2 & HT A2, C14
07630031738684n!ce® C, LT A2 & LT A3, C14
07630031738677n!ce® C, HT A2 & HT A3, C14
07630031738660n!ce® C, HT A3, C14
07630031738653n!ce® C, HT A2, C14
07630031738646n!ce® C, LT A3, C14
07630031738639n!ce® C, LT A2, C14
07630031734891n!ce®, HT Bleach, C14
07630031734853n!ce®, LT Bleach, C14
07630031734679n!ce® C, HT A3.5, C14
07630031734662n!ce® C, HT B1, C14
07630031734655n!ce® C, HT Bleach, C14
07630031734631n!ce® C, LT A3.5, C14
07630031734624n!ce® C, LT B1, C14
07630031734617n!ce® C, LT Bleach, C14
07630031704528n!ce® C, HT C2, C14
07630031704511n!ce® C, HT B4, C14
07630031704504n!ce® C, HT B2, C14
07630031704498n!ce® C, HT A3, C14
07630031704481n!ce® C, HT A2, C14
07630031704474n!ce® C, HT A1, C14
07630031704467n!ce® C, LT C2, C14
07630031704450n!ce® C, LT B4, C14
07630031704443n!ce® C, LT B2, C14
07630031704436n!ce® C, LT A3, C14
07630031704429n!ce® C, LT A2, C14
07630031704412n!ce® C, LT A1, C14
07630031730961n!ce® Inlay, XshadeX
07630031730954n!ce® Onlay, XshadeX
07630031730947n!ce® Veneer, XshadeX
07630031730930n!ce® Partial Crown, XshadeX
07630031730923n!ce® Crown, XshadeX

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