KeyPrint 4200011
GUDID H66842000112
KeySplint Hard Clear Resin 0.5 KG
Keystone Industries
Dental appliance fabrication material, resin| Primary Device ID | H66842000112 |
| NIH Device Record Key | 675e004e-dce9-45af-9ff7-5f50f38603d3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KeyPrint |
| Version Model Number | 4200011 |
| Catalog Number | 4200011 |
| 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 |
Device Dimensions
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
| Weight | 0.5 Kilogram |
| Total Volume | 17.6 Fluid Ounce |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | H66842000111 [Primary] |
| HIBCC | H66842000112 [Package] Contains: H66842000111 Package: box [8 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K203000
FDA Product Code
| EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-28 |
| Device Publish Date | 2023-02-20 |
On-Brand Devices [KeyPrint]
| H66842201551 | Keysplint Soft Clear for Carbon 1kg |
| H66842200051 | Keysplint Soft 1 kg |
| H66842001551 | Keysplint Soft Clear for Carbon sample |
| H66842000051 | Keysplint Soft sample |
| H66842200042 | KeySplint Hard 1 kg |
| H66842000042 | KeySplint Hard 0.5 kg sample |
| H66850522011 | KeyGuide 0.5 KG for Nexa 3D Printers |
| H66842204201 | KeyDenture Try In, BL4, 1 KG |
| H66842204061 | KeyDenture Try In, B1, 1 KG |
| H66842204011 | KeyDenture Try In, A1, 1 KG |
| H66842200081 | KeyOrtho IBT 1KG |
| H66842200011 | KeyGuide 1 KG |
| H66842004201 | KeyDenture Try In, BL4, 0.5 KG |
| H66842004061 | KeyDenture Try In, B1, 0.5 KG |
| H66842004011 | KeyDenture Try In, A1, 0.5 KG |
| H66842000081 | KeyOrtho IBT 0.5KG |
| H66842000011 | KeyGuide 0.5 KG |
| H66842201612 | KeySplint Soft Clear Resin ,1kg |
| H66842200112 | KeySplint Hard Clear Resin 1kg |
| H66842001612 | KeySplint Soft Clear Resin, 0.5kg |
| H66842000112 | KeySplint Hard Clear Resin 0.5 KG |
| H66842201512 | KeySplint Soft Pink 1kg |
| H66841101412 | KeySplint Hard Pink 1kg |
| H66842000100 | 3D Intro Kit |
| H6684200432 | KeyDenture Base Chroma Essence 0.5kg |
| H66842004311 | KeyDenture Base Dark Veined 0.5kg |
| H66842004301 | KeyDenture BAse Original 0.5kg |
| H66842204341 | KeyDenture Base Light Reddish Pink 1kg |
| H66842204331 | KeyDenture Base Light Pink 1kg |
| H66842204321 | KeyDenture Base Chroma Essence 1kg |
| H66842204311 | KeyDenture Base Dark Veined 1kg |
| H66842204301 | KeyDenture Base Original 1kg |
| H66842004341 | KeyDenture Base Light Reddish Pink 0.5kg |
| H66842004331 | KeyDenture Base Light Pink 0.5kg |
Trademark Results [KeyPrint]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KEYPRINT 87551440 5439871 Live/Registered |
Mycone Dental Supply Co., Inc. 2017-08-01 |
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