Zerion Alpha, Zerion Beta 010.0001

GUDID 07630031701299

zerion HSC zirconium oxide ceramic single unit

Institut Straumann AG

Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic Custom-made dental crown, ceramic
Primary Device ID07630031701299
NIH Device Record Keyaa547c28-165c-4b7a-ae06-73951a38b416
Commercial Distribution StatusIn Commercial Distribution
Brand NameZerion Alpha, Zerion Beta
Version Model NumberCopings
Catalog Number010.0001
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(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107630031701299 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIHPOWDER, PORCELAIN

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


[07630031701299]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-03-10
Device Publish Date2019-08-14

On-Brand Devices [Zerion Alpha, Zerion Beta]

07630031701299zerion HSC zirconium oxide ceramic single unit
07630031701282zerion HSC zirconium oxide ceramic primary crown
07630031701442zerion HSC zirconium oxide ceramic 16 units bridge framework
07630031701435zerion HSC zirconium oxide ceramic 15 units bridge framework
07630031701428zerion HSC zirconium oxide ceramic 14 units bridge framework
07630031701411zerion HSC zirconium oxide ceramic 13 units bridge framework
07630031701404zerion HSC zirconium oxide ceramic 12 units bridge framework
07630031701398zerion HSC zirconium oxide ceramic 11 units bridge framework
07630031701381zerion HSC zirconium oxide ceramic 10 units bridge framework
07630031701374zerion HSC zirconium oxide ceramic 9 units bridge framework
07630031701367zerion HSC zirconium oxide ceramic 8 units bridge framework
07630031701350zerion HSC zirconium oxide ceramic 7 units bridge framework
07630031701343zerion HSC zirconium oxide ceramic 6 units bridge framework
07630031701336zerion HSC zirconium oxide ceramic 5 units bridge framework
07630031701329zerion HSC zirconium oxide ceramic 4 units bridge framework
07630031701312zerion HSC zirconium oxide ceramic 3 units bridge framework
07630031701305zerion HSC zirconium oxide ceramic 2 units bridge framework

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