FDA.reportPublic FDA data

NobelReplace®

Primary DI
07332747000580
Brand
NobelReplace®
Company
Nobel Biocare AB
Model
31637
Catalog number
31637
Device description
Immediate Temporary Abutment NobRpl NP
Published
2015-09-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM
NHAAbutment, implant, dental, endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961737000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961737000CERA ONE ABUTMENT SYSTEMNobelpharma USA, Inc.1996-07-10DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332747000580PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332747000580073327470005807332747000580

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
353939929
Device count
1
Lot or batch
true
Expiration date on label
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
08800070203156ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203217ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203231ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203248ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203255ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203262ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203279ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203286ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203309ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203316ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203323ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203330ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203347ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203354ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203361ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203378ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203385ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203392ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203408ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800075200051I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200068I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200075I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200082I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200099I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200105I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200112I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200129I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200136I DoOneday Biotech Co.,Ltd.DZE2026-06-04