FDA.reportPublic FDA data

PRIMUS Implant System

Primary DI
00810112920437
Brand
PRIMUS Implant System
Company
Inosys, Inc.
Model
PBHA 603R
Device description
Biotem AR HEALING ABUTMENTØ5.65 X 3(C:2 , H:1)
Published
2022-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K171297000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171297000AR_N Type Implant SystemBiotem Co., Ltd.2018-01-31DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810112920437PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810112920437008101129204378101129204370810112920437

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
101803383
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810112921625Pick-Up Impression Coping(Non-Hex)PBIP M45SN2024-02-13
00810112921632Pick-Up Impression Coping(Non-Hex)PBIP M45LN2024-02-13
00810112921649Pick-Up Impression Coping(Non-Hex)PBIP R45SN2024-02-13
00810112921656Pick-Up Impression Coping(Non-Hex)PBIP R45LN2024-02-13
00810112921571Fixture Lab AnalogPBFAN M35H2022-06-17
00810112921588Fixture Lab AnalogPBFAN R37H2022-06-17
00810112921595Fixture Lab AnalogPBFAN R40H2022-06-17
00810112921120PRIMUS Implant SystemPBCA R4555N2022-06-15
00810112921137PRIMUS Implant SystemPBCA R4565N2022-06-15
00810112921144PRIMUS Implant SystemPBCA R4517N2022-06-15
00810112921151PRIMUS Implant SystemPBCA R4527N2022-06-15
00810112921168PRIMUS Implant SystemPBCA R4537N2022-06-15
00810112921175PRIMUS Implant SystemPBCA R4547N2022-06-15
00810112921182PRIMUS Implant SystemPBCA R5514N2022-06-15
00810112921199PRIMUS Implant SystemPBCA R5524N2022-06-15
00810112921205PRIMUS Implant SystemPBCA R5534N2022-06-15
00810112921212PRIMUS Implant SystemPBCA R5544N2022-06-15
00810112921229PRIMUS Implant SystemPBCA R5515N2022-06-15
00810112921236PRIMUS Implant SystemPBCA R5525N2022-06-15
00810112921243PRIMUS Implant SystemPBCA R5535N2022-06-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092170199PreatPreat CorporationNHA2026-06-09
00842092174999PreatPreat CorporationNHA2026-06-09
04260516873062SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873079SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873086SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873093SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873109SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873116SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873338SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873345SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873352SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873369SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873376SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873628SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874465SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874472SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874533SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874540SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874557SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874564SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874571SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874700SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874717SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874724SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874731SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874748SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874755SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874809SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874816SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874830SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08