| Primary Device ID | D745701120GLH00010 |
| NIH Device Record Key | 8c2afc56-31fd-4507-ad08-ed41c4c867df |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Glidewell™ |
| Version Model Number | 70-1120-GLH0001 |
| Catalog Number | 70-1120-GLH0001 |
| Company DUNS | 022761689 |
| Company Name | Prismatik Dentalcraft, Inc |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | D745701120GLH00010 [Primary] |
| EGS | Handpiece, contra- and right-angle attachment, 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 | 2025-12-02 |
| Device Publish Date | 2025-11-24 |
| D745701204WPS00011 | Glidewell™ Curing Light Kit |
| D745701071PRS00050 | Autoclavable Cassette for Glidewell™ Prosthetic Kit |
| D745701071PRS00040 | Glidewell™ Prosthetic Kit |
| D745701120GLH00030 | Glidewell™ Contra-angle Electric Low-Speed Handpiece GL-11L |
| D745701120GLH00020 | Glidewell™ Contra-angle Electric High-Speed Handpiece GL-15L |
| D745701120GLH00010 | Glidewell™ Contra-angle Electric High-Speed Handpiece GL-45L |