| Primary Device ID | D87745967CERECKIT11 | 
| NIH Device Record Key | fb1e4e09-eea5-4554-b615-ddf87c14e816 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | dental bur and polisher kit | 
| Version Model Number | 45967CERECKIT1 | 
| Catalog Number | 45967CERECKIT1 | 
| Company DUNS | 600028195 | 
| Company Name | STRAUSS & CO - INDUSTRIAL DIAMONDS LTD | 
| 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 | true | 
| Serial Number | false | 
| Manufacturing Date | true | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | D87745967CERECKIT11 [Primary] | 
| DZP | Instrument, Diamond, Dental | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2024-08-06 | 
| Device Publish Date | 2024-07-29 | 
| D877A10C60 - dental diamond bur | 2024-11-12 Round+Neck diamond bur Coarse grit | 
| D877A10F60 - dental diamond bur | 2024-11-12 Round+Neck diamond bur Fine grit | 
| D877A125F60 - dental diamond bur | 2024-11-12 Round+Neck diamond bur Fine grit | 
| D87745967CERECKIT3 - Dental Bur and polisher Kit | 2024-10-30 Cerec Emax Adjustment Set | 
| D87745967COMSET1 - Dental Bur SET | 2024-10-30 COMPOSITE SET | 
| D87745967ENDOSET1 - Dental Bur SET | 2024-10-30 Endodontic Set | 
| D87745967IPRKIT1 - Dental Bur SET | 2024-10-30 Interproximal Reductions Set | 
| D87745967KIT1 - Dental Bur and polisher set | 2024-10-30 Zirconia adjustment kit |