Primary Device ID | D745701190PRA00230 |
NIH Device Record Key | 7b524e69-8f59-4c1a-bee4-771cd656ea76 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Glidewell HT™ |
Version Model Number | 70-1190-PRA0023 |
Catalog Number | 70-1190-PRA0023 |
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 | 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 | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D745701190PRA00230 [Primary] |
NHA | Abutment, 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 |