FDA.reportPublic FDA data

PrimeLoc

Primary DI
00810053770108
Brand
PrimeLoc
Company
IPB
Model
LOC50002-10
Device description
Standard Range Processing Pack with Enhanced Denture Housing, 10 Pack
Published
2020-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EGGAttachment, Precision, All
EIEDam, Rubber

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGGAttachment, Precision, AllDental1
EIEDam, RubberDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810053770108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810053770108008100537701088100537701080810053770108

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
High-level Disinfectant

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809262955514FineDamSpident Co., Ltd.EIE2026-10-07
00840481138423LOCATOR, compatible with Nobel BiocareZest Anchors, LLCEGG2026-09-29
00840481138454LOCATOR, compatible with Nobel BiocareZest Anchors, LLCEGG2026-09-29
00840481138478LOCATOR, compatible with Nobel BiocareZest Anchors, LLCEGG2026-09-29
08800076418523T-L Cap SetTruabutment Korea Co.,LtdEGG2026-09-04
08059224151519OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224151526OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224160993OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224161006OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224161013OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224161037OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224161044OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224161051OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224197746OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224197753OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224197760OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224197777OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224197784OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224197791OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224218571PLUSRHEIN 83 SRLEGG2026-08-27
08059224218588PLUSRHEIN 83 SRLEGG2026-08-27
08059224218595PLUSRHEIN 83 SRLEGG2026-08-27
08059224218601PLUSRHEIN 83 SRLEGG2026-08-27
08059224218618PLUSRHEIN 83 SRLEGG2026-08-27
08059224218625PLUSRHEIN 83 SRLEGG2026-08-27
08059224218632PLUSRHEIN 83 SRLEGG2026-08-27
08059224218649PLUSRHEIN 83 SRLEGG2026-08-27
08059224218656PLUSRHEIN 83 SRLEGG2026-08-27
08059224218663PLUSRHEIN 83 SRLEGG2026-08-27
08059224218670PLUSRHEIN 83 SRLEGG2026-08-27