Enamelite 5100184

GUDID H66851001841

AEROpaque Spray Opaque Shade A3

Keystone Industries

Dental appliance fabrication material, ceramic
Primary Device IDH66851001841
NIH Device Record Key22b80a7c-b31f-4b2c-bdf0-20f463ee6883
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnamelite
Version Model Number5100184
Catalog Number5100184
Company DUNS073503117
Company NameKeystone Industries
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com

Device Dimensions

Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram
Weight110 Gram

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, SpecifyBetween 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCH66851001841 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-24
Device Publish Date2016-09-15

On-Brand Devices [Enamelite]

H66851002141Aeropaque Z-Liner, Shade Clear Small
H66851001971AEROpaque Spray Opaque Shade D3 Medium
H66851001961AEROpaque Spray Opaque Shade D2 Medium
H66851001911AEROpaque Spray Opaque Shade Base Medium
H66851001881AEROpaque Spray Opaque Shade B2 Medium
H66851001871AEROpaque Spray Opaque Shade B1
H66851001861AEROpaque Spray Opaque Shade A4 Medium
H66851001851AEROpaque Spray Opaque Shade A3.5
H66851001841AEROpaque Spray Opaque Shade A3
H66851001831AEROpaque Spray Opaque Shade A2
H66851001821AEROpaque Spray Opaque Shade A1
H66851001811Low-Fusing Nova Fluorescent Ceramic Spray Glaze Small
H66851001801Nova Ceramic Spray Glaze Small
H66851001791Nova Ceramic Spray Glaze Medium

Trademark Results [Enamelite]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ENAMELITE
ENAMELITE
78412449 3027076 Live/Registered
MYCONE DENTAL SUPPLY CO., INC.
2004-05-03
ENAMELITE
ENAMELITE
78129790 2898045 Live/Registered
MYCONE DENTAL SUPPLY CO., INC.
2002-05-19
ENAMELITE
ENAMELITE
72414774 0963724 Dead/Expired
LEE PHARMACEUTICALS
1972-02-07
ENAMELITE
ENAMELITE
72339410 0912171 Dead/Expired
ACORN PRODUCTS COMPANY
1969-10-01
ENAMELITE
ENAMELITE
71537719 0505765 Dead/Expired
NILES ROLLING MILL COMPANY, THE
1947-10-13

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