KeyMill 1009311
GUDID H66810093111
High Impact Denture Acrylic Disc, Orig
Keystone Industries
Dental appliance fabrication material, cured| Primary Device ID | H66810093111 |
| NIH Device Record Key | f2d4a817-ef64-4af8-9e20-591f393f61ab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KeyMill |
| Version Model Number | 1009311 |
| Catalog Number | 1009311 |
| 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 | true |
| 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 |
Device Dimensions
| Width | 30 Millimeter |
| Width | 30 Millimeter |
| Width | 30 Millimeter |
| Width | 30 Millimeter |
| Width | 30 Millimeter |
| Width | 30 Millimeter |
| Width | 30 Millimeter |
| Width | 30 Millimeter |
| Width | 30 Millimeter |
| Width | 30 Millimeter |
| Width | 30 Millimeter |
| Width | 30 Millimeter |
| Width | 30 Millimeter |
| Width | 30 Millimeter |
| Width | 30 Millimeter |
| Width | 30 Millimeter |
| Width | 30 Millimeter |
| Width | 30 Millimeter |
| Width | 30 Millimeter |
| Width | 30 Millimeter |
| Width | 30 Millimeter |
| Width | 30 Millimeter |
| Width | 30 Millimeter |
| Width | 30 Millimeter |
| Width | 30 Millimeter |
| Width | 30 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | H66810093111 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K172764
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 | 2019-01-10 |
| Device Publish Date | 2018-12-10 |
On-Brand Devices [KeyMill]
| H66810093131 | High Impact Denture Acrylic Disc, LRP |
| H66810093121 | High Impact Denture Acrylic Disc, LRP |
| H66810093111 | High Impact Denture Acrylic Disc, Orig |
| H66810093101 | High Impact Denture Acrylic Disc, Orig |
Trademark Results [KeyMill]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KEYMILL 87873364 not registered Live/Pending |
Mycone Dental Supply Co., Inc. 2018-04-11 |
 KEYMILL 76383172 2758178 Dead/Cancelled |
KUBOTEK CORPORATION 2002-03-15 |
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