Enamelite 5100214
GUDID H66851002141
Aeropaque Z-Liner, Shade Clear Small
Keystone Industries
Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic| Primary Device ID | H66851002141 |
| NIH Device Record Key | 72a5d3a1-49fc-4a7d-8dda-2525e338e2c2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Enamelite |
| Version Model Number | 5100214 |
| Catalog Number | 5100214 |
| Company DUNS | 073503117 |
| Company Name | Keystone Industries |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com |
Device Dimensions
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
| Weight | 110 Gram |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temps above 120°F may cause can to burst and cause injury |
| Special Storage Condition, Specify | Between 0 and 0 *avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | H66851002141 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K030859
FDA Product Code
| EIH | POWDER, PORCELAIN |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-24 |
| Device Publish Date | 2016-09-15 |
On-Brand Devices [Enamelite]
| H66851002141 | Aeropaque Z-Liner, Shade Clear Small |
| H66851001971 | AEROpaque Spray Opaque Shade D3 Medium |
| H66851001961 | AEROpaque Spray Opaque Shade D2 Medium |
| H66851001911 | AEROpaque Spray Opaque Shade Base Medium |
| H66851001881 | AEROpaque Spray Opaque Shade B2 Medium |
| H66851001871 | AEROpaque Spray Opaque Shade B1 |
| H66851001861 | AEROpaque Spray Opaque Shade A4 Medium |
| H66851001851 | AEROpaque Spray Opaque Shade A3.5 |
| H66851001841 | AEROpaque Spray Opaque Shade A3 |
| H66851001831 | AEROpaque Spray Opaque Shade A2 |
| H66851001821 | AEROpaque Spray Opaque Shade A1 |
| H66851001811 | Low-Fusing Nova Fluorescent Ceramic Spray Glaze Small |
| H66851001801 | Nova Ceramic Spray Glaze Small |
| H66851001791 | Nova Ceramic Spray Glaze Medium |
Trademark Results [Enamelite]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENAMELITE 78412449 3027076 Live/Registered |
MYCONE DENTAL SUPPLY CO., INC. 2004-05-03 |
 ENAMELITE 78129790 2898045 Live/Registered |
MYCONE DENTAL SUPPLY CO., INC. 2002-05-19 |
 ENAMELITE 72414774 0963724 Dead/Expired |
LEE PHARMACEUTICALS 1972-02-07 |
 ENAMELITE 72339410 0912171 Dead/Expired |
ACORN PRODUCTS COMPANY 1969-10-01 |
 ENAMELITE 71537719 0505765 Dead/Expired |
NILES ROLLING MILL COMPANY, THE 1947-10-13 |
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