Endo-Eze AET Contra Angle 3219-

GUDID 00883205021076

ENDO CONTRA ANGLE LOANER

ULTRADENT PRODUCTS, INC.

Dental laboratory drilling system motor
Primary Device ID00883205021076
NIH Device Record Keyf26abc78-d737-4747-805e-0c128675cd42
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndo-Eze AET Contra Angle
Version Model Number3219-
Catalog Number3219-
Company DUNS013369913
Company NameULTRADENT PRODUCTS, 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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(801)572-4200
Emailcustomerservice@ultradent.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100883205021076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EFBHandpiece, air-powered, dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00883205021076]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-05
Device Publish Date2018-09-04

Devices Manufactured by ULTRADENT PRODUCTS, INC.

00883205030177 - White Mac Tip2024-12-25 White Mac Tips 10pk
00883205030900 - VALO2024-12-25 VALO GRAND SAPPHIRE (Cordless)
00883205030917 - VALO2024-12-25 VALO GRAND RED ROCK (CORDLESS)
00883205030924 - VALO2024-12-25 VALO GRAND MIDNIGHT (CORDLESS)
00883205031587 - Thermo Clone VPS2024-12-25 Thermo Clone VPS Fast Set Superlight Body 2x50 ml Refill Kit
00883205031709 - Thermo Clone2024-12-25 Thermo Clone VPS Fast Set Light Body 10x50 ml Bulk Pack
00883205031716 - Thermo Clone2024-12-25 Thermo Clone VPS Fast Set Heavy 10x50 ml Bulk Pack
00883205031860 - Gishy Goo2024-12-25 Gishy Goo! One-Patient Kit Tooth Color

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.