Plastic Impression Coping PIC

GUDID 08806388230471

Common L=9

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed
Primary Device ID08806388230471
NIH Device Record Keyd7742465-8fa5-48ba-8f91-63a673475aec
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlastic Impression Coping
Version Model NumberPIC
Catalog NumberPIC
Company DUNS687388178
Company NameMegagen Implant Co. Ltd
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 Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
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
GS108806388230471 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806388230471]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2015-07-27

Devices Manufactured by Megagen Implant Co. Ltd

08806388207381 - Impression Coping2026-03-02
08806388207398 - Impression Coping2026-03-02 Ø3.5/ L=10/ 1-Piece/ Transfer
08806388207404 - Impression Coping2026-03-02 Ø3.5/ L=14/ 1-Piece/ Transfer
08806388244362 - Narrow Crest Drill2026-03-02 Regular/ Ø4/ L=18.5
08806388244379 - Narrow Crest Drill2026-03-02 Regular/ Ø5/ L=18.5
08806388244553 - Hand Driver2026-03-02 Slot 0.5/ Short
08806388244560 - Hand Driver2026-03-02 Slot 0.5/ Long
08806388247486 - Handpiece Connector2026-03-02 Hex3.55/ L=25

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.