FDA.reportPublic FDA data

NobelProcera®

Primary DI
07332747179644
Brand
NobelProcera®
Company
Nobel Biocare AB
Model
86692
Catalog number
86692
Device description
NobelProcera® Zirconia Bridge 4u OM2
Published
2020-12-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELLTEETH, PORCELAIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELLTeeth, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162043000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162043000NobelProcera HT ML FCZ BridgeNobel Biocare AB2016-11-22ELL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332747179644PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332747179644073327471796447332747179644

GMDN Terms#

Term, Definition table
TermDefinition
Dental bridge, ceramicA custom-made, non-removable, artificial replacement for one or more missing teeth made entirely of ceramic/porcelain material and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight. Keep dry

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)322-5001us.customerservice@nobelbiocare.com

Regulatory Flags#

DUNS number
353939929
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332747214918Nobel Biocare®3019313019312026-04-09
07332747214925Nobel Biocare®3019323019322026-04-09
07332747214932Nobel Biocare®3019333019332026-04-09
07332747214949Nobel Biocare®3019343019342026-04-09
07332747221510Nobel Biocare®3022543022542026-04-09
07332747221527Nobel Biocare®3022553022552026-04-09
07332747221534Nobel Biocare®3022563022562026-04-09
07332747223385Nobel Biocare®3022653022652026-04-09
07332747223392Nobel Biocare®3022643022642026-04-09
07332747223408Nobel Biocare®3022663022662026-04-09
07332747224436Nobel Biocare®3024853024852026-04-09
07332747224443Nobel Biocare®3024863024862026-04-09
07332747224450Nobel Biocare®3024883024882026-04-09
07332747224467Nobel Biocare®3024873024872026-04-09
07332747224474Nobel Biocare®3024893024892026-04-09
07332747224481Nobel Biocare®3024903024902026-04-09
07332747236620DTX Studio™ Clinic4.83008512026-03-27
07332747236637DTX Studio™ Clinic4.83008512026-03-27
07332747219616DTX Studio™ Clinic4.43008512025-01-26
07332747219623DTX Studio™ Clinic4.43008512025-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979878380078Jiahong dental labShenzhen Jiahong Dental Technology Co.,Ltd.ELL2026-04-03
06975409640055ZrcoopHangzhou Thales Medtech Co., Ltd.ELL2025-01-03
06975409640062ZrcoopHangzhou Thales Medtech Co., Ltd.ELL2025-01-03
06975409640079ZrcoopHangzhou Thales Medtech Co., Ltd.ELL2025-01-03
06975409641007ZrcoopHangzhou Thales Medtech Co., Ltd.ELL2025-01-03
E23561010VINTAGESHOFU DENTAL CORPORATIONELL2021-02-03
E23561020VINTAGESHOFU DENTAL CORPORATIONELL2021-02-03
E23566850VINTAGE MARGINSHOFU DENTAL CORPORATIONELL2021-02-03
E23569010VINTAGE OPALSHOFU DENTAL CORPORATIONELL2021-02-03
E23569040VINTAGE OPALSHOFU DENTAL CORPORATIONELL2021-02-03
E23569050VINTAGE OPALSHOFU DENTAL CORPORATIONELL2021-02-03
07332747179569NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179576NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179583NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179590NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179606NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179613NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179620NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179637NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179651NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179668NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179675NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179682NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179699NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179705NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179712NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179729NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179736NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179743NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179750NobelProcera®Nobel Biocare ABELL2020-12-11