DENTCA Tray

GUDID 00856551007124

EZ Tracer

DENTCA, INC.

Dental impression tray, single-use
Primary Device ID00856551007124
NIH Device Record Key3fa182c0-7964-48fa-b037-007e26bc13ee
Commercial Distribution StatusIn Commercial Distribution
Brand NameDENTCA Tray
Version Model NumberDENTCA EZ Tracer
Company DUNS022455143
Company NameDENTCA, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100856551007124 [Primary]

FDA Product Code

EHYTray, Impression, Preformed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-11
Device Publish Date2021-11-03

On-Brand Devices [DENTCA Tray]

00856551007193Starter Kit
00856551007186Single Arch Attachment (Upper & Lower) - Large & Extra Large
00856551007179Single Arch Attachment (Upper & Lower) - Small & Medium
00856551007162Tray - Small
00856551007155Tray - Medium
00856551007148Tray - Large
00856551007131Tray - Extra Large
00856551007124EZ Tracer
00856551007117Jaw Gauge
00856551007100Lip Ruler

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