Enamelite 5100188
GUDID H66851001881
AEROpaque Spray Opaque Shade B2 Medium
Keystone Industries
Dental appliance fabrication material, ceramic| Primary Device ID | H66851001881 |
| NIH Device Record Key | e7f7ea11-3a8f-4f53-bd22-c7b54abe5ac2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Enamelite |
| Version Model Number | 5100188 |
| Catalog Number | 5100188 |
| 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 | H66851001881 [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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