FDA.reportPublic FDA data

PrimeLoc

Primary DI
00810053770474
Brand
PrimeLoc
Company
IPB
Model
LOC50070
Device description
15mm Abutment Driver, Packaged, Primeloc Attachment System
Published
2020-08-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EIFAccessories, Retractor, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIFAccessories, Retractor, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810053770474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810053770474008100537704748100537704740810053770474

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
Dry Heat Sterilization

Regulatory Flags#

DUNS number
784984267
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810053771891PrimeLocLOC50003-102022-12-15
00810053771037DentMixIMD50046-10-DM2022-11-02
00810053771044DentMixIMD50046-24-DM2022-11-02
00810053771051DentMixIMD50107-DM2022-11-02
00810053771068DentMixIMD50107-2-DM2022-11-02
00810053771075DentMixIMD50107-4-DM2022-11-02
00810053771082DentMixIMD50107-10-DM2022-11-02
00810053771099DentMixIMD50107-24-DM2022-11-02
00810053771150DentMixIMD50040-DM2022-11-02
00810053771167DentMixIMD50040-2-DM2022-11-02
00810053771174DentMixIMD50040-4-DM2022-11-02
00810053771181DentMixIMD50040-10-DM2022-11-02
00810053771198DentMixIMD50040-24-DM2022-11-02
00810053771204DentMixIMD50114-50-DM2022-11-02
00810053771211DentMixIMD50115-50-DM2022-11-02
00810053771228DentMixIMD50116-100-DM2022-11-02
00810053771235DentMixIMD500422022-11-02
00810053771242DentMixIMD500432022-11-02
00810053771259DentMixIMD500442022-11-02
00810053771266DentMixIMD50047-DM2022-11-02

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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