| Primary Device ID | D745701190PRC00230 |
| NIH Device Record Key | 2c0db2b6-49c0-4384-95df-2abeff1302ac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Glidewell HT™ |
| Version Model Number | 70-1190-PRC0023 |
| Catalog Number | 70-1190-PRC0023 |
| Company DUNS | 022761689 |
| Company Name | Prismatik Dentalcraft, Inc |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| 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 | D745701190PRC00230 [Primary] |
| NDP | Accessories, implant, dental, endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-29 |
| Device Publish Date | 2024-03-21 |
| D745701190PRS00180 | Glidewell HT™ Implant Multi-Unit Coping 4.5 mmH, Non-Engaging |
| D745701190PRS00170 | Glidewell HT™ Implant Multi-Unit Abutment 4.5 mmH - Ø5.0 Implant |
| D745701190PRS00160 | Glidewell HT™ Implant Multi-Unit Abutment 3.5 mmH - Ø5.0 Implant |
| D745701190PRS00150 | Glidewell HT™ Implant Multi-Unit Abutment 3.5 mmH - Ø3.5/4.3 Implant |
| D745701190PRS00140 | Glidewell HT™ Implant Multi-Unit Abutment 3.5 mmH - Ø3.0 Implant |
| D745701190PRS00130 | Glidewell HT™ Implant Multi-Unit Abutment 2.5 mmH - Ø5.0 Implant |
| D745701190PRS00120 | Glidewell HT™ Implant Multi-Unit Abutment 2.5 mmH - Ø3.5/4.3 Implant |
| D745701190PRS00110 | Glidewell HT™ Implant Multi-Unit Abutment 2.5 mmH - Ø3.0 Implant |
| D745701190PRS00100 | Glidewell HT™ Implant Multi-Unit Abutment 1.5 mmH - Ø5.0 Implant |
| D745701190PRS00090 | Glidewell HT™ Implant Multi-Unit Abutment 1.5 mmH - Ø3.5/4.3 Implant |
| D745701190PRS00080 | Glidewell HT™ Implant 30° Multi-Unit Abutment 4.5 mmH - Ø5.0 Implant |
| D745701190PRS00070 | Glidewell HT™ Implant 30° Multi-Unit Abutment 4.5 mmH - Ø3.5/4.3 Implant |
| D745701190PRS00060 | Glidewell HT™ Implant 30° Multi-Unit Abutment 3.5 mmH - Ø5.0 Implant |
| D745701190PRS00050 | Glidewell HT™ Implant 30° Multi-Unit Abutment 3.5 mmH - Ø3.5/4.3 Implant |
| D745701190PRS00040 | Glidewell HT™ Implant 17° Multi-Unit Abutment 3.5 mmH - Ø5.0 Implant |
| D745701190PRS00030 | Glidewell HT™ Implant 17° Multi-Unit Abutment 3.5 mmH - Ø3.5/4.3 Implant |
| D745701190PRS00020 | Glidewell HT™ Implant 17° Multi-Unit Abutment 2.5 mmH - Ø5.0 Implant |
| D745701190PRS00010 | Glidewell HT™ Implant 17° Multi-Unit Abutment 2.5 mmH - Ø3.5/4.3 Implant |
| D745701190PRC00530 | Glidewell HT™ Implant Handpiece Prosthetic Driver, Short |
| D745701190PRC00520 | Glidewell HT™ Implant Handpiece Prosthetic Driver, Long |
| D745701190PRC00510 | Glidewell HT™ Implant Prosthetic Driver, Short |
| D745701190PRC00500 | Glidewell HT™ Implant Prosthetic Driver, Long |
| D745701190PRC00490 | Glidewell HT™ Implant Guide Pin - Ø5.0/7.0 Implant |
| D745701190PRC00480 | Glidewell HT™ Implant Guide Pin - Ø3.5/4.3 Implant |
| D745701190PRC00470 | Glidewell HT™ Implant Guide Pin - Ø3.0 Implant |
| D745701190PRC00460 | Glidewell HT™ Implant Multi-Unit Titanium Scan Body with Prosthetic Screw |
| D745701190PRC00450 | Glidewell HT™ Implant Multi-Unit Digital Abutment Analog |
| D745701190PRC00440 | Glidewell HT™ Digital Implant Analog - Ø7.0 Implant |
| D745701190PRC00430 | Glidewell HT™ Digital Implant Analog - Ø5.0 Implant |
| D745701190PRC00420 | Glidewell HT™ Digital Implant Analog - Ø4.3 Implant |
| D745701190PRC00410 | Glidewell HT™ Digital Implant Analog - Ø3.5 Implant |
| D745701190PRC00400 | Glidewell HT™ Digital Implant Analog - Ø3.0 Implant |
| D745701190PRC00390 | Glidewell HT™ Implant Analog - Ø7.0 Implant |
| D745701190PRC00380 | Glidewell HT™ Implant Analog - Ø5.0 Implant |
| D745701190PRC00370 | Glidewell HT™ Implant Analog - Ø4.3 Implant |
| D745701190PRC00360 | Glidewell HT™ Implant Analog - Ø3.5 Implant |
| D745701190PRC00350 | Glidewell HT™ Implant Analog - Ø3.0 Implant |
| D745701190PRC00340 | Glidewell HT™ Digital Implant Analog Retention Screw |
| D745701190PRC00330 | Glidewell HT™ Implant Angled Multi-Unit Abutment Screw - Ø5.0 Implant |
| D745701190PRC00320 | Glidewell HT™ Implant Angled Multi-Unit Abutment Screw - Ø3.5/4.3 Implant |
| D745701190PRC00310 | Glidewell HT™ Implant Titanium Screw - Ø5.0/7.0 Implant |
| D745701190PRC00300 | Glidewell HT™ Implant Titanium Screw - Ø3.5/4.3 Implant |
| D745701190PRC00290 | Glidewell HT™ Implant Titanium Screw - Ø3.0 Implant |
| D745701190PRC00280 | Glidewell HT™ Implant Open-Tray Impression Coping 5 mmH - Ø7.0 Implant |
| D745701190PRC00270 | Glidewell HT™ Implant Open-Tray Impression Coping 3 mmH - Ø7.0 Implant |
| D745701190PRC00260 | Glidewell HT™ Implant Open-Tray Impression Coping 7 mmH - Ø5.0 Implant |
| D745701190PRC00250 | Glidewell HT™ Implant Open-Tray Impression Coping 5 mmH - Ø5.0 Implant |
| D745701190PRC00240 | Glidewell HT™ Implant Open-Tray Impression Coping 3 mmH - Ø5.0 Implant |
| D745701190PRC00230 | Glidewell HT™ Implant Open-Tray Impression Coping 7 mmH - Ø4.3 Implant |
| D745701190PRC00220 | Glidewell HT™ Implant Open-Tray Impression Coping 5 mmH - Ø4.3 Implant |