| Primary Device ID | 08806383544313 | 
| NIH Device Record Key | 53517f5a-db27-4489-b43f-f707ecf7c001 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | GATE DRILLS | 
| Version Model Number | 28m/m ASST 1/6 | 
| Catalog Number | 531-191 | 
| Company DUNS | 687789453 | 
| Company Name | DiaDent Group International | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| 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 | false | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 08806383544313 [Primary] | 
| DZA | Drill, Dental, Intraoral | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[08806383544313]
Moist Heat or Steam Sterilization
[08806383544313]
Moist Heat or Steam Sterilization
[08806383544313]
Moist Heat or Steam Sterilization
[08806383544313]
Moist Heat or Steam Sterilization
[08806383544313]
Moist Heat or Steam Sterilization
[08806383544313]
Moist Heat or Steam Sterilization
[08806383544313]
Moist Heat or Steam Sterilization
[08806383544313]
Moist Heat or Steam Sterilization
[08806383544313]
Moist Heat or Steam Sterilization
[08806383544313]
Moist Heat or Steam Sterilization
[08806383544313]
Moist Heat or Steam Sterilization
[08806383544313]
Moist Heat or Steam Sterilization
[08806383544313]
Moist Heat or Steam Sterilization
[08806383544313]
Moist Heat or Steam Sterilization
[08806383544313]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2020-06-23 | 
| Device Publish Date | 2020-06-15 | 
| 08806383544467 | GATE DRILLS is used for time-saving preparation of the upper and middle part of non-curved canal | 
| 08806383544450 | GATE DRILLS is used for time-saving preparation of the upper and middle part of non-curved canal | 
| 08806383544443 | GATE DRILLS is used for time-saving preparation of the upper and middle part of non-curved canal | 
| 08806383544436 | GATE DRILLS is used for time-saving preparation of the upper and middle part of non-curved canal | 
| 08806383544429 | GATE DRILLS is used for time-saving preparation of the upper and middle part of non-curved canal | 
| 08806383544382 | GATE DRILLS is used for time-saving preparation of the upper and middle part of non-curved canal | 
| 08806383544375 | GATE DRILLS is used for time-saving preparation of the upper and middle part of non-curved canal | 
| 08806383544368 | GATE DRILLS is used for time-saving preparation of the upper and middle part of non-curved canal | 
| 08806383544351 | GATE DRILLS is used for time-saving preparation of the upper and middle part of non-curved canal | 
| 08806383544344 | GATE DRILLS is used for time-saving preparation of the upper and middle part of non-curved canal | 
| 08806383544337 | GATE DRILLS is used for time-saving preparation of the upper and middle part of non-curved canal | 
| 08806383544320 | GATE DRILLS is used for time-saving preparation of the upper and middle part of non-curved canal | 
| 08806383544313 | GATE DRILLS is used for time-saving preparation of the upper and middle part of non-curved canal | 
| 08806383544283 | GATE DRILLS is used for time-saving preparation of the upper and middle part of non-curved canal |