TPC ALED55N

GUDID D861ALED55N0

LED light cure

TPC ADVANCE TECHNOLOGY, INC.

Dental laboratory curing unit
Primary Device IDD861ALED55N0
NIH Device Record Keyd078a933-3446-40c6-af51-04627f00db96
Commercial Distribution StatusIn Commercial Distribution
Brand NameTPC
Version Model NumberALED55N
Catalog NumberALED55N
Company DUNS968884275
Company NameTPC ADVANCE TECHNOLOGY, INC.
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 Usefalse
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

Customer Support Contacts

Phone6268104337
Emailsbeckley@tpcdental.com
Phone6268104337
Emailsbeckley@tpcdental.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD861ALED55N0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBZActivator, Ultraviolet, For Polymerization

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-09-11

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D861ALED70N0LED light cure
D861ALED60N0LED light cure
D861ALED55N0LED light cure
D861ALED55BN0LED Built In Curing Light
D861ALED500LED light cure
D861ALED25000LED light cure
D861A850LED0A850LED
D861A800N0scaler to remove calculus
D861A800LED0scaler to remove calculus
D861A750N0scaler to remove calculus
D861A750LED0scaler with led to remove calculus

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