Ceramco 3 303620

GUDID D0013036200

Ceramco 3 Shade Series Opaqueous Dentin 423 10g

Dentsply Professional

Dental appliance fabrication material, ceramic
Primary Device IDD0013036200
NIH Device Record Keyfa685472-3af6-43f2-a836-1a5454a1546e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCeramco 3
Version Model Number303620
Catalog Number303620
Company DUNS144140845
Company NameDentsply Professional
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 Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)243-1942
EmailProsthetics-Regualtory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regualtory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regualtory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regualtory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regualtory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regualtory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regualtory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regualtory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regualtory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regualtory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regualtory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regualtory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regualtory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regualtory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regualtory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regualtory@dentsplysirona.com
Phone+1(800)243-1942
EmailProsthetics-Regualtory@dentsplysirona.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD0013036200 [Primary]

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 Date2024-10-11
Device Publish Date2024-10-03

On-Brand Devices [Ceramco 3]

D0013059650Ceramco 3 HC6 Dentin Modifier 10g
D0013059640Ceramco 3 HC5 Dentin Modifier 10g
D0013059630Ceramco 3 HC4 Dentin Modifier 10g
D0013059620Ceramco 3 HC3 Dentin Modifier 10g
D0013059610Ceramco 3 HC2 Dentin Modifier 10g
D0013059600Ceramco 3 HC1 Dentin Modifier 10g
D0013059150Ceramco 3 Margin GREEN-BROWN 10g
D0013059110Ceramco 3 Margin HONEY-YELLOW 10g
D0013059070Ceramco 3 Margin C1 10g
D0013059050Ceramco 3 Margin A4 10g
D0013059030Ceramco 3 Margin A1 10g
D0013059020Ceramco 3 Margin I5 10g
D0013059010Ceramco 3 Margin I2 10g
D0013059000Ceramco 3 Margin I1 10g
D0013054080Ceramco 3 Add-On DARK Tissue Tint 10g
D0013054060Ceramco 3 Add-On REDDISH PINK Tissue Tint 10
D0013054020Ceramco 3 Add-On LIGHT 10g
D0013054010Ceramco 3 Add-On WHITE 10g
D0013054000Ceramco 3 Add-On TRANSLUCENT 10g
D0013052240Ceramco 3 Enamel WHITE TRANSPARENT 10g
D0013052230Ceramco 3 Opal Enamel CLEAR 10g
D0013052200Ceramco 3 Opal Enamel WHITE 10g
D0013052120Ceramco 3 Natural Enamel SUPER CLEAR 10g
D0013052110Ceramco 3 Natural Enamel CLEAR 10g
D0013052100Ceramco 3 Natural Enamel YELLOW 10g
D0013052090Ceramco 3 Natural Enamel PINK 10g
D0013052080Ceramco 3 Natural Enamel BLUE 10g
D0013052050Ceramco 3 Natural Enamel IVORY 10g
D0013052040Ceramco 3 Natural Enamel DARK 10g
D0013052030Ceramco 3 Natural Enamel MEDIUM 10g
D0013052020Ceramco 3 Natural Enamel LIGHT 10g
D0013052000Ceramco 3 Natural Enamel WHITE 10g
D0013051750Ceramco 3 Dentin Modifier INTENSE ORANGE 10g
D0013051740Ceramco 3 Dentin Modifier NEUTRAL 10g
D0013051730Ceramco 3 Dentin Modifier ORANGE 10g
D0013051710Ceramco 3 Dentin Modifier PINK 10g
D0013051700Ceramco 3 Dentin Modifier GRAY 10g
D0013051690Ceramco 3 Dentin Modifier VIOLET 10g
D0013051680Ceramco 3 Dentin Modifier YELLOW 10g
D0013051530Ceramco 3 Dentin D4 10g
D0013051520Ceramco 3 Dentin D3 10g
D0013051510Ceramco 3 Dentin D2 10g
D0013051500Ceramco 3 Dentin C4 10g
D0013051490Ceramco 3 Dentin C3 10g
D0013051480Ceramco 3 Dentin C2 10g
D0013051470Ceramco 3 Dentin C1 10g
D0013051460Ceramco 3 Dentin B4 10g
D0013051450Ceramco 3 Dentin B3 10g
D0013051430Ceramco 3 Dentin B1 10g
D0013051420Ceramco 3 Dentin I2 10g

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