PURE Ceramic Implants 031.321

GUDID 07630031714244

ND Protective Cap, AH 5.5 mm, PEEK

Institut Straumann AG

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID07630031714244
NIH Device Record Key1e203b81-34b6-4bf0-b0d7-6e4d1380d4ee
Commercial Distribution StatusIn Commercial Distribution
Brand NamePURE Ceramic Implants
Version Model Number1
Catalog Number031.321
Company DUNS483599259
Company NameInstitut Straumann AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)448-8168
Emailinfo.usa@straumann.com

Device Dimensions

Device Size Text, specify0
Outer Diameter3.3 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS107630031714244 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630031714244]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-07
Device Publish Date2016-01-14

On-Brand Devices [PURE Ceramic Implants]

07630031714268RD Protective Cap, AH 5.5mm, PEEK
07630031714251RD Protective Cap, AH 4mm, PEEK
07630031714244ND Protective Cap, AH 5.5 mm, PEEK
07630031714237ND Protective Cap, AH 4.0 mm, PEEK
07630031714220RD Temporary Coping, for Bridge, PMMA
07630031714213RD Temporary Coping, for Crown, PMMA
07630031714206ND Temporary Coping, for bridge, PMMA
07630031714190ND Temporary Coping, for crown, PMMA
07630031714015Straumann® PURE Ceramic Implant Monotype, Ø 4.1mm RD, ZLA 14mm, AH 5.5mm, ZrO2
07630031713995Straumann® PURE Ceramic Implant Monotype, Ø 4.1mm RD, ZLA 12mm, AH 5.5mm, ZrO2
07630031713971Straumann® PURE Ceramic Implant Monotype, Ø 4.1mm RD, ZLA 10mm, AH 5.5mm, ZrO2
07630031713957Straumann® PURE Ceramic Implant Monotype, Ø 4.1mm RD, ZLA 8mm, AH 5.5mm, ZrO2
07630031713933Straumann® PURE Ceramic Implant Monotype, Ø 4.1mm RD, ZLA 14mm, AH 4mm, ZrO2
07630031713919Straumann® PURE Ceramic Implant Monotype, Ø 4.1mm RD, ZLA 12mm, AH 4mm, ZrO2
07630031713896Straumann® PURE Ceramic Implant Monotype, Ø 4.1mm RD, ZLA 10mm, AH 4mm, ZrO2
07630031713872Straumann® PURE Ceramic Implant Monotype, Ø 4.1mm RD, ZLA 8mm, AH 4mm, ZrO2
07630031713858Straumann® PURE Ceramic Implant Monotype, Ø 3.3mm ND, ZLA 14mm, AH 5.5mm, ZrO2
07630031713841Straumann® PURE Ceramic Implant Monotype, Ø 3.3mm ND, ZLA 12mm, AH 5.5mm, ZrO2
07630031713834Straumann® PURE Ceramic Implant Monotype, Ø 3.3mm ND, ZLA 10mm, AH 5.5mm, ZrO2
07630031713827Straumann® PURE Ceramic Implant Monotype, Ø 3.3mm ND, ZLA 8mm, AH 5.5mm, ZrO2
07630031713810Straumann® PURE Ceramic Implant Monotype, Ø 3.3mm ND, ZLA 14mm, AH 4mm, ZrO2
07630031713803Straumann® PURE Ceramic Implant Monotype, Ø 3.3mm ND, ZLA 12mm, AH 4mm, ZrO2
07630031713797Straumann® PURE Ceramic Implant Monotype, Ø 3.3mm ND, ZLA 10mm, AH 4mm, ZrO2
07630031713780Straumann® PURE Ceramic Implant Monotype, Ø 3.3mm ND, ZLA 8mm, AH 4mm, ZrO2
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