FDA.report

Preat

Primary DI
00842092166383
Brand
Preat
Company
Implants and Attachments, Inc.
Model
0103004
Catalog number
0103004
Device description
Roto Wax Wheels Large (50-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
EJQWHEEL, POLISHING AGENT

Product Code Classifications

CodeDeviceSpecialtyClass
EJQWheel, Polishing AgentDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842092172537PrimaryGS10
00842092166383Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842092172537008420921725378420921725370842092172537
00842092166383008420921663838420921663830842092166383

GMDN Terms

TermDefinition
Dental abrasive disk, reusableA dental instrument consisting of a circular flat or slightly conical sheet carrying or containing an abrasive, intended to perform a circular and/or oscillatory motion for polishing and finishing a cavity preparation and/or for cutting or polishing dental restorations. It is designed to be fixed at its centre to a mandrel and intended to be used with a dental power tool handpiece (e.g., straight or contra-angle). This is a reusable device.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
054875224
Device count
50
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
false

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
07630243636051KENDADent4You AGEJQ2025-09-17
07630243636075KENDADent4You AGEJQ2025-09-17
07630243636082KENDADent4You AGEJQ2025-09-17
07630243636105KENDADent4You AGEJQ2025-09-17
07630243636112KENDADent4You AGEJQ2025-09-17
07630243636099KENDADent4You AGEJQ2025-09-17
07630243641406KENDADent4You AGEJQ2025-09-17
07630243641413KENDADent4You AGEJQ2025-09-17
07630243636068KENDADent4You AGEJQ2025-09-17
07630243636228KENDADent4You AGEJQ2025-09-17
07630243636235KENDADent4You AGEJQ2025-09-17
07630243636242KENDADent4You AGEJQ2025-09-17
07630243636259KENDADent4You AGEJQ2025-09-17
07630243636273KENDADent4You AGEJQ2025-09-17
07630243636280KENDADent4You AGEJQ2025-09-17
07630243636266KENDADent4You AGEJQ2025-09-17
07630243641727KENDADent4You AGEJQ2025-09-17
07630243637225KENDADent4You AGEJQ2025-09-17
07630243637232KENDADent4You AGEJQ2025-09-17
07630243637249KENDADent4You AGEJQ2025-09-17
07630243637256KENDADent4You AGEJQ2025-09-17
07630243637362KENDADent4You AGEJQ2025-09-17
07630243637379KENDADent4You AGEJQ2025-09-17
07630243637386KENDADent4You AGEJQ2025-09-17
07630243637393KENDADent4You AGEJQ2025-09-17
07630243642052KENDADent4You AGEJQ2025-09-17
07630243642069KENDADent4You AGEJQ2025-09-17
07630243636709KENDADent4You AGEJQ2025-09-17
07630243636716KENDADent4You AGEJQ2025-09-17
07630243636730KENDADent4You AGEJQ2025-09-17