PROPHY SPORT TDC5544-1

GUDID 00810988030957

TDC PROPHY SPORT HYGIENIST HP

HANDPIECE PARTS & REPAIRS, INC.

Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic
Primary Device ID00810988030957
NIH Device Record Keydcc9f498-aa8c-4e41-97f9-de185c877539
Commercial Distribution StatusIn Commercial Distribution
Brand NamePROPHY SPORT
Version Model NumberTDC5544-1
Catalog NumberTDC5544-1
Company DUNS079723355
Company NameHANDPIECE PARTS & REPAIRS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810988030957 [Primary]

FDA Product Code

EFBHandpiece, Air-Powered, Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810988030957]

Moist Heat or Steam Sterilization


[00810988030957]

Moist Heat or Steam Sterilization


[00810988030957]

Moist Heat or Steam Sterilization


[00810988030957]

Moist Heat or Steam Sterilization


[00810988030957]

Moist Heat or Steam Sterilization


[00810988030957]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-27
Device Publish Date2022-05-19

Devices Manufactured by HANDPIECE PARTS & REPAIRS, INC.

00810988030827 - QUALITY PLUS2023-07-25 QUALITY PLUS PEDO 4-HOLE HANDPIECE
00810988031848 - MEDIDENTA2023-07-18 Medidenta Medilectric 40K Brushless/ LED/ Motor Only
00810988031312 - EDGE ENDO2023-04-28 EdgeApex Measuring File
00810988031336 - EDGE ENDO2023-04-28 EdgeApex Measuring Wire
00810988031350 - EDGE ENDO2023-04-28 EdgeApex Tester
00810988031374 - EDGE ENDO2023-04-28 EdgePack Downpack Unit
00810988031404 - EDGE ENDO2023-04-28 EdgePack 3504 Tip
00810988031411 - EDGE ENDO2023-04-28 EdgePack 4004 Tip

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