FDA.report

Preat

Primary DI
00842092166406
Brand
Preat
Company
Implants and Attachments, Inc.
Model
0109005
Catalog number
0109005
Device description
Perma Ret Twist Drill (3-Pack)
Published
2022-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
DZADRILL, DENTAL, INTRAORAL

Product Code Classifications

CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842092172551PrimaryGS10
00842092166406Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842092172551008420921725518420921725510842092172551
00842092166406008420921664068420921664060842092166406

GMDN Terms

TermDefinition
Steel dental bur, single-useA rotary cutting device made from high-grade carbon steel with the working end typically formed with cutting planes, e.g., spiralled flutes, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a single-use device.

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
3
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
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

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