ET Bite Impression Coping

GUDID 00810126043122

HIOSSEN, INC.

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID00810126043122
NIH Device Record Key4a980aa7-fb16-40a6-b097-af4364044016
Commercial Distribution StatusIn Commercial Distribution
Brand NameET Bite Impression Coping
Version Model NumberETBICR5640HC
Company DUNS796083090
Company NameHIOSSEN, 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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810126043122 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-25
Device Publish Date2025-04-17

On-Brand Devices [ ET Bite Impression Coping]

00810126043122ETBICR5640HC
00810126042507ETBICM4620HC

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