FDA.report

PrimeLoc

Primary DI
00810053770245
Brand
PrimeLoc
Company
IPB
Model
LOC50021-2
Device description
Extended Range Processing Pack, 2 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
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EGGAttachment, Precision, All

Product Code Classifications

CodeDeviceSpecialtyClass
EGGAttachment, Precision, AllDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810053770245PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810053770245008100537702458100537702450810053770245

GMDN Terms

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
High-level Disinfectant

Regulatory Flags

DUNS number
784984267
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
00810053771273DentMixIMD50048-DM2022-11-02

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840481136023LOCATOR, compatible with Implant DirectZest Anchors, LLCEGG2026-02-18
00840481136917LOCATOR R-Tx, Dentsply Sirona System Zest Anchors, LLCEGG2026-02-18
00840481136924LOCATOR R-Tx, Dentsply Sirona System Zest Anchors, LLCEGG2026-02-18
07640239932562Dalbo®-ClassicCendres+Métaux SAEGG2026-02-16
07640239932579Dalbo®-ClassicCendres+Métaux SAEGG2026-02-16
08059224127798OT EQUATORRHEIN 83 SRLEGG2026-02-10
08059224129044PLUSRHEIN 83 SRLEGG2026-02-10
08059224129099PLUSRHEIN 83 SRLEGG2026-02-10
08059224129143PLUSRHEIN 83 SRLEGG2026-02-10
08059224133041OT EQUATORRHEIN 83 SRLEGG2026-02-10
08059224133058OT EQUATORRHEIN 83 SRLEGG2026-02-10
08059224134260OT EQUATORRHEIN 83 SRLEGG2026-02-10
08059224167503PLUSRHEIN 83 SRLEGG2026-02-10
08059224167510PLUSRHEIN 83 SRLEGG2026-02-10
08059224167534PLUSRHEIN 83 SRLEGG2026-02-10
08059224167541PLUSRHEIN 83 SRLEGG2026-02-10
08059224167558PLUSRHEIN 83 SRLEGG2026-02-10
08059224167565PLUSRHEIN 83 SRLEGG2026-02-10
08059224167572PLUSRHEIN 83 SRLEGG2026-02-10
08059224167589PLUSRHEIN 83 SRLEGG2026-02-10
08059224167596PLUSRHEIN 83 SRLEGG2026-02-10
08059224167602PLUSRHEIN 83 SRLEGG2026-02-10
08059224167619PLUSRHEIN 83 SRLEGG2026-02-10
08059224167626PLUSRHEIN 83 SRLEGG2026-02-10
08059224167633PLUSRHEIN 83 SRLEGG2026-02-10
08059224167640OT EQUATORRHEIN 83 SRLEGG2026-02-10
08059224185040OT CAPRHEIN 83 SRLEGG2026-02-10
08059224209234OT CAPRHEIN 83 SRLEGG2026-02-10
08059224209241OT CAPRHEIN 83 SRLEGG2026-02-10
08059224209272OT CAPRHEIN 83 SRLEGG2026-02-10