Replace Select™ 37319

GUDID 07332747160994

Replace Select™ Tapered PMC 6.0 6.0x16mm

Nobel Biocare AB

Screw endosteal dental implant, two-piece
Primary Device ID07332747160994
NIH Device Record Key2c367d3a-9bad-41fc-bb32-929e274c23c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameReplace Select™
Version Model Number37319
Catalog Number37319
Company DUNS353939929
Company NameNobel Biocare AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com

Device Dimensions

Length16 Millimeter
Outer Diameter6 Millimeter
Length16 Millimeter
Outer Diameter6 Millimeter
Length16 Millimeter
Outer Diameter6 Millimeter
Length16 Millimeter
Outer Diameter6 Millimeter
Length16 Millimeter
Outer Diameter6 Millimeter
Length16 Millimeter
Outer Diameter6 Millimeter
Length16 Millimeter
Outer Diameter6 Millimeter
Length16 Millimeter
Outer Diameter6 Millimeter
Length16 Millimeter
Outer Diameter6 Millimeter
Length16 Millimeter
Outer Diameter6 Millimeter
Length16 Millimeter
Outer Diameter6 Millimeter
Length16 Millimeter
Outer Diameter6 Millimeter
Length16 Millimeter
Outer Diameter6 Millimeter
Length16 Millimeter
Outer Diameter6 Millimeter
Length16 Millimeter
Outer Diameter6 Millimeter
Length16 Millimeter
Outer Diameter6 Millimeter
Length16 Millimeter
Outer Diameter6 Millimeter
Length16 Millimeter
Outer Diameter6 Millimeter
Length16 Millimeter
Outer Diameter6 Millimeter
Length16 Millimeter
Outer Diameter6 Millimeter
Length16 Millimeter
Outer Diameter6 Millimeter
Length16 Millimeter
Outer Diameter6 Millimeter
Length16 Millimeter
Outer Diameter6 Millimeter
Length16 Millimeter
Outer Diameter6 Millimeter
Length16 Millimeter
Outer Diameter6 Millimeter
Length16 Millimeter
Outer Diameter6 Millimeter
Length16 Millimeter
Outer Diameter6 Millimeter
Length16 Millimeter
Outer Diameter6 Millimeter
Length16 Millimeter
Outer Diameter6 Millimeter
Length16 Millimeter
Outer Diameter6 Millimeter
Length16 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107332747160994 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-24
Device Publish Date2019-07-16

On-Brand Devices [Replace Select™]

07332747159974Replace Select™ Tapered TiU 6.0 6.0x13mm
07332747159967Replace Select™ Tapered TiU 6.0 6.0x10mm
07332747159721Replace Select™ Tapered TiU WP 5.0x16mm
07332747159714Replace Select™ Tapered TiU WP 5.0x13mm
07332747159707Replace Select™ Tapered TiU WP 5.0x10mm
07332747159691Replace Select™ Tapered TiU RP 4.3x16mm
07332747159684Replace Select™ Tapered TiU RP 4.3x13mm
07332747159677Replace Select™ Tapered TiU RP 4.3x10mm
07332747159660Replace Select™ Tapered TiU NP 3.5x16mm
07332747159653Replace Select™ Tapered TiU NP 3.5x13mm
07332747159646Replace Select™ Tapered TiU NP 3.5x10mm
07332747160994Replace Select™ Tapered PMC 6.0 6.0x16mm
07332747160987Replace Select™ Tapered PMC 6.0 6.0x13mm
07332747160970Replace Select™ Tapered PMC 6.0 6.0x11.5mm
07332747160963Replace Select™ Tapered PMC 6.0 6.0x10mm
07332747160956Replace Select™ Tapered PMC 6.0 6.0x8mm
07332747160949Replace Select Tapered PMC WP 5.0x16mm
07332747160932Replace Select Tapered PMC WP 5.0x13mm
07332747160925Replace Select Tapered PMC WP 5.0x11.5mm
07332747160918Replace Select Tapered PMC WP 5.0x10mm
07332747160901Replace Select Tapered PMC WP 5.0x8mm
07332747160895Replace Select Tapered PMC RP 4.3x16mm
07332747160888Replace Select Tapered PMC RP 4.3x13mm
07332747160871Replace Select Tapered PMC RP 4.3x11.5mm
07332747160864Replace Select Tapered PMC RP 4.3x10mm
07332747160857Replace Select Tapered PMC RP 4.3x8mm
07332747160840Replace Select Tapered PMC NP 3.5x16mm
07332747160833Replace Select Tapered PMC NP 3.5x13mm
07332747160826Replace Select Tapered PMC NP 3.5x11.5mm
07332747160819Replace Select Tapered PMC NP 3.5x10mm
07332747160802Replace Select Tapered PMC NP 3.5x8mm
07332747160444Replace Select™ TC RP 4.0x(15+3)mm
07332747160437Replace Select™ TC RP 4.0x(13+3)mm
07332747160420Replace Select™ TC RP 4.0x(10+3)mm
07332747160413Replace Select™ TC RP 4.0x(7+3)mm
07332747160406Replace Select™ TC NP 3.5x(15+3)mm
07332747160390Replace Select™ TC NP 3.5x(13+3)mm
07332747160383Replace Select™ TC NP 3.5x(10+3)mm
07332747160376Replace Select™ TC NP 3.5x(7+3)mm
07332747160369Replace Select™ Tapered TiU 6.0 6.0x11.5mm
07332747160352Replace Select™ Tapered TiU 6.0 6.0x8mm
07332747160345Replace Select™ Tapered TiU WP 5.0x11.5mm
07332747160338Replace Select™ Tapered TiU WP 5.0x8mm
07332747160321Replace Select™ Tapered TiU RP 4.3x11.5mm
07332747160314Replace Select™ Tapered TiU RP 4.3x8mm
07332747160307Replace Select™ Tapered TiU NP 3.5x11.5mm
07332747160291Replace Select™ Tapered TiU NP 3.5x8mm

Trademark Results [Replace Select]

Mark Image

Registration | Serial
Company
Trademark
Application Date
REPLACE SELECT
REPLACE SELECT
75781095 2556731 Dead/Cancelled
NOBEL BIOCARE USA, LLC
1999-08-20

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