FDA.reportPublic FDA data

Prima

Primary DI
D76802550901111K0
Brand
Prima
Company
KEYSTONE DENTAL, INC.
Model
15789K
Device description
Healing Abutment
Published
2017-12-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051614000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051614000PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICSLifecore Biomedical, Inc.2005-09-09DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D76802550901111K0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)902-9272info@keystonedental.com

Regulatory Flags#

DUNS number
787471015
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D76802538901111K0Prima02-541901111K2017-12-13
D76802541901111K0Prima02-540901111K2017-12-13
D76815300K0Prima15300K15300K2016-02-04
D76815301K0Prima15301K15301K2016-02-04
D76815302K0Prima15302K15302K2016-02-04
D76815303K0Prima15303K15303K2016-02-04
D76815304K0Prima15304K15304K2016-02-04
D76815305K0Prima15305K15305K2016-02-04
D76815306K0Prima15306K15306K2016-02-04
D76815307K0Prima15307K15307K2016-02-04
D76815308K0Prima15308K15308K2016-02-04
D76815309K0Prima15309K15309K2016-02-04
D76815310K0Prima15310K15310K2016-02-04
D76815311K0Prima15311K15311K2016-02-04
D76815312K0Prima15312K15312K2016-02-04
D76815313K0Prima15313K15313K2016-02-04
D76815314K0Prima15314K15314K2016-02-04
D76815315K0Prima15315K15315K2016-02-04
D76815316K0Prima15316K15316K2016-02-04
D76815317K0Prima15317K15317K2016-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809918260054LW Narrow Solid AbutmentOssvis Co., Ltd.NHA2026-10-22
08809918260085LW Narrow Solid AbutmentOssvis Co., Ltd.NHA2026-10-22
08809984988135S-PlantIDIS CO.,LTDNHA2026-10-22
08809984988210S-PlantIDIS CO.,LTDNHA2026-10-22
08809984988296S-PlantIDIS CO.,LTDNHA2026-10-22
08809984988333S-PlantIDIS CO.,LTDNHA2026-10-22
08809984988371S-PlantIDIS CO.,LTDNHA2026-10-22
08809984988418S-PlantIDIS CO.,LTDNHA2026-10-22
08809984988456S-PlantIDIS CO.,LTDNHA2026-10-22
08809984987886S-PlantIDIS CO.,LTDNHA2026-10-21
08809984987909S-PlantIDIS CO.,LTDNHA2026-10-21
08809984987923S-PlantIDIS CO.,LTDNHA2026-10-21
08809984987947S-PlantIDIS CO.,LTDNHA2026-10-21
08809984987961S-PlantIDIS CO.,LTDNHA2026-10-21
08809984987985S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988005S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988029S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988043S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988067S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988098S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988173S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988258S-PlantIDIS CO.,LTDNHA2026-10-21
088000968494068plant Implant System8dent Inc.NHA2026-10-20
088000968498338plant Implant System8dent Inc.NHA2026-10-20
088000968514618plant Implant System8dent Inc.NHA2026-10-20
088000968514788plant Implant System8dent Inc.NHA2026-10-20
088000968514858plant Implant System8dent Inc.NHA2026-10-20
088000968515778plant Implant System8dent Inc.NHA2026-10-20
088000968611568plant Implant System8dent Inc.NHA2026-10-20
088000968621608plant Implant System8dent Inc.NHA2026-10-20