PURE Ceramic Implants 031.014S

GUDID 07630031713858

Straumann® PURE Ceramic Implant Monotype, Ø 3.3mm ND, ZLA 14mm, AH 5.5mm, ZrO2

Institut Straumann AG

Screw endosteal dental implant, one-piece
Primary Device ID07630031713858
NIH Device Record Keye41f576d-9488-407c-83a2-f7a5f621d3a5
Commercial Distribution StatusIn Commercial Distribution
Brand NamePURE Ceramic Implants
Version Model Number1
Catalog Number031.014S
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 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
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 Dimensions

Outer Diameter3.3 Millimeter
Device Size Text, specify0
Length14 Millimeter
Outer Diameter3.3 Millimeter
Device Size Text, specify0
Length14 Millimeter
Outer Diameter3.3 Millimeter
Device Size Text, specify0
Length14 Millimeter
Outer Diameter3.3 Millimeter
Device Size Text, specify0
Length14 Millimeter
Outer Diameter3.3 Millimeter
Device Size Text, specify0
Length14 Millimeter
Outer Diameter3.3 Millimeter
Device Size Text, specify0
Length14 Millimeter
Outer Diameter3.3 Millimeter
Device Size Text, specify0
Length14 Millimeter
Outer Diameter3.3 Millimeter
Device Size Text, specify0
Length14 Millimeter
Outer Diameter3.3 Millimeter
Device Size Text, specify0
Length14 Millimeter
Outer Diameter3.3 Millimeter
Device Size Text, specify0
Length14 Millimeter
Outer Diameter3.3 Millimeter
Device Size Text, specify0
Length14 Millimeter
Outer Diameter3.3 Millimeter
Device Size Text, specify0
Length14 Millimeter
Outer Diameter3.3 Millimeter
Device Size Text, specify0
Length14 Millimeter
Outer Diameter3.3 Millimeter
Device Size Text, specify0
Length14 Millimeter
Outer Diameter3.3 Millimeter
Device Size Text, specify0
Length14 Millimeter
Outer Diameter3.3 Millimeter
Device Size Text, specify0
Length14 Millimeter
Outer Diameter3.3 Millimeter
Device Size Text, specify0
Length14 Millimeter
Outer Diameter3.3 Millimeter
Device Size Text, specify0
Length14 Millimeter
Outer Diameter3.3 Millimeter
Device Size Text, specify0
Length14 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107630031713858 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-01-20

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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