FDA.report

Preat

Primary DI
00842092168554
Brand
Preat
Company
Implants and Attachments, Inc.
Model
2141CTE
Catalog number
2141CTE
Device description
Equator Ti Housings (2-Pack)
Published
2022-10-24
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

Contact Domains

Product Codes

CodeName
EGGATTACHMENT, PRECISION, ALL

Product Code Classifications

CodeDeviceSpecialtyClass
EGGAttachment, Precision, AllDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842092173183PrimaryGS10
00842092168554Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842092173183008420921731838420921731830842092173183
00842092168554008420921685548420921685540842092168554

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800) 232-7732lauren@preat.com
+1(800) 232-7732info@preat.com

Regulatory Flags

DUNS number
054875224
Device count
2
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00842092101063NobelBiocare™ Tri-Lobe-compatible 800055180005512023-08-10
00842092177105Preat Implant Prosthetics900373290037322022-11-03
00842092110591Universal IC Attachment120011212001122022-10-28
00842092174432Preat Implant Prosthetics1500150P1500150P2022-10-28
00842092161470Preat Implant Prosthetics900477790047772022-11-03
00842092161487Preat Implant Prosthetics900477890047782022-11-03
00842092161494Preat Implant Prosthetics900477990047792022-11-03
00842092161500Preat Implant Prosthetics900478990047892022-11-03
00842092161524Preat Implant Prosthetics900478090047802022-11-03
00842092161548Preat Implant Prosthetics900478190047812022-11-03
00842092161562Preat Implant Prosthetics1604701C1604701C2022-11-03
00842092161586Preat Implant Prosthetics1604702C1604702C2022-11-03
00842092161609Preat Implant Prosthetics1604703C1604703C2022-11-03
00842092161623Preat Implant Prosthetics1604704C1604704C2022-11-03
00842092161708Preat Implant Prosthetics900475090047502022-11-03
00842092161654Preat Implant Prosthetics900476190047612022-11-03
00842092161678Preat Implant Prosthetics900476290047622022-11-03
00842092161692Preat Implant Prosthetics900475990047592022-11-03
00842092161715Preat Implant Prosthetics900472190047212022-11-03
00842092161722Preat Implant Prosthetics900472290047222022-11-03

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