ECLIPSE Kiss

GUDID 00860001538120

AMSUSA LLC

Dental porcelain/ceramic restoration kit
Primary Device ID00860001538120
NIH Device Record Keyacd50dd9-a9f7-4811-bd2b-f32a9f0b4bdd
Commercial Distribution StatusIn Commercial Distribution
Brand NameECLIPSE Kiss
Version Model NumberUS
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
GS100860001538120 [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 Plus2025-05-13 Zirconia disc
00860001538120 - ECLIPSE Kiss2025-05-13
00860001538120 - ECLIPSE Kiss2025-05-13
00860001538144 - ECLIPSE 2.0 Plus Shade Disk2025-05-13
00860001538168 - ECLIPSE Multi2025-05-13

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