ECLIPSE 2.0 Plus

GUDID 00860001538106

Zirconia disc

AMSUSA LLC

Dental porcelain/ceramic restoration kit
Primary Device ID00860001538106
NIH Device Record Key3245d707-9422-4663-ac61-f628985c6f64
Commercial Distribution StatusIn Commercial Distribution
Brand NameECLIPSE 2.0 Plus
Version Model NumberUZ
Company DUNS062739116
Company NameAMSUSA LLC
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860001538106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIHPowder, Porcelain

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-13
Device Publish Date2025-05-05

Devices Manufactured by AMSUSA LLC

00860001538106 - ECLIPSE 2.0 Plus2025-05-13Zirconia disc
00860001538106 - ECLIPSE 2.0 Plus2025-05-13 Zirconia disc
00860001538120 - ECLIPSE Kiss2025-05-13
00860001538144 - ECLIPSE 2.0 Plus Shade Disk2025-05-13
00860001538168 - ECLIPSE Multi2025-05-13

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