Primary Device ID | D745701072PRC00680 |
NIH Device Record Key | f7c5c131-c666-4b4f-8e13-5c3ba3726184 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Glidewell IH™ |
Version Model Number | 70-1072-PRC0068 |
Catalog Number | 70-1072-PRC0068 |
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 | D745701072PRC00680 [Primary] |
NDP | Accessories, implant, dental, endosseous |
Steralize Prior To Use | true |
Device Is Sterile | false |
[D745701072PRC00680]
Moist Heat or Steam Sterilization
[D745701072PRC00680]
Moist Heat or Steam Sterilization
[D745701072PRC00680]
Moist Heat or Steam Sterilization
[D745701072PRC00680]
Moist Heat or Steam Sterilization
[D745701072PRC00680]
Moist Heat or Steam Sterilization
[D745701072PRC00680]
Moist Heat or Steam Sterilization
[D745701072PRC00680]
Moist Heat or Steam Sterilization
[D745701072PRC00680]
Moist Heat or Steam Sterilization
[D745701072PRC00680]
Moist Heat or Steam Sterilization
[D745701072PRC00680]
Moist Heat or Steam Sterilization
[D745701072PRC00680]
Moist Heat or Steam Sterilization
[D745701072PRC00680]
Moist Heat or Steam Sterilization
[D745701072PRC00680]
Moist Heat or Steam Sterilization
[D745701072PRC00680]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-06-27 |
Device Publish Date | 2025-06-19 |
D745701207IMP00190 | Glidewell IH™ Implant Healing Abutment 3.0 mmP x 3.2 mmD x 3 mmH |
D745701207IMP00180 | Glidewell IH™ Implant Healing Abutment 4.5 mmP x 5.7 mmD x 7 mmH |
D745701207IMP00170 | Glidewell IH™ Implant Healing Abutment 4.5 mmP x 5.7 mmD x 5 mmH |
D745701207IMP00160 | Glidewell IH™ Implant Healing Abutment 4.5 mmP x 5.7 mmD x 3 mmH |
D745701207IMP00150 | Glidewell IH™ Implant Healing Abutment 4.5 mmP x 4.5 mmD x 7 mmH |
D745701207IMP00140 | Glidewell IH™ Implant Healing Abutment 4.5 mmP x 4.5 mmD x 5 mmH |
D745701207IMP00130 | Glidewell IH™ Implant Healing Abutment 4.5 mmP x 4.5 mmD x 3 mmH |
D745701207IMP00120 | Glidewell IH™ Implant Healing Abutment 3.5 mmP x 4.7 mmD x 7 mmH |
D745701207IMP00110 | Glidewell IH™ Implant Healing Abutment 3.5 mmP x 4.7 mmD x 5 mmH |
D745701207IMP00100 | Glidewell IH™ Implant Healing Abutment 3.5 mmP x 4.7 mmD x 3 mmH |
D745701207IMP00090 | Glidewell IH™ Implant Healing Abutment 3.5 mmP x 3.5 mmD x 7 mmH |
D745701207IMP00080 | Glidewell IH™ Implant Healing Abutment 3.5 mmP x 3.5 mmD x 5 mmH |
D745701207IMP00070 | Glidewell IH™ Implant Healing Abutment 3.5 mmP x 3.5 mmD x 3 mmH |
D745701207IMP00060 | Glidewell IH™ Implant Healing Abutment 3.0 mmP x 3.7 mmD x 7 mmH |
D745701207IMP00050 | Glidewell IH™ Implant Healing Abutment 3.0 mmP x 3.7 mmD x 5 mmH |
D745701207IMP00040 | Glidewell IH™ Implant Healing Abutment 3.0 mmP x 3.7 mmD x 3 mmH |
D745701207IMP00030 | Glidewell IH™ Implant Healing Abutment 3.0 mmP x 3.2 mmD x 7 mmH |
D745701207IMP00020 | Glidewell IH™ Implant Healing Abutment 3.0 mmP x 3.2 mmD x 5 mmH |
D745701206IMP00270 | Glidewell IH™ Implant 5.2 mmD x 16 mmL x 4.5 mmP |
D745701206IMP00260 | Glidewell IH™ Implant 5.2 mmD x 13 mmL x 4.5 mmP |
D745701206IMP00250 | Glidewell IH™ Implant 5.2 mmD x 11.5 mmL x 4.5 mmP |
D745701206IMP00240 | Glidewell IH™ Implant 5.2 mmD x 10 mmL x 4.5 mmP |
D745701206IMP00230 | Glidewell IH™ Implant 5.2 mmD x 8 mmL x 4.5 mmP |
D745701206IMP00220 | Glidewell IH™ Implant 4.7 mmD x 16 mmL x 4.5 mmP |
D745701206IMP00210 | Glidewell IH™ Implant 4.7 mmD x 13 mmL x 4.5 mmP |
D745701206IMP00200 | Glidewell IH™ Implant 4.7 mmD x 11.5 mmL x 4.5 mmP |
D745701206IMP00190 | Glidewell IH™ Implant 4.7 mmD x 10 mmL x 4.5 mmP |
D745701206IMP00180 | Glidewell IH™ Implant 4.7 mmD x 8 mmL x 4.5 mmP |
D745701206IMP00170 | Glidewell IH™ Implant 4.2 mmD x 16 mmL x 3.5 mmP |
D745701206IMP00160 | Glidewell IH™ Implant 4.2 mmD x 13 mmL x 3.5 mmP |
D745701206IMP00150 | Glidewell IH™ Implant 4.2 mmD x 11.5 mmL x 3.5 mmP |
D745701206IMP0014 | Glidewell IH™ Implant 4.2 mmD x 10 mmL x 3.5 mmP |
D745701206IMP0013 | Glidewell IH™ Implant 4.2 mmD x 8 mmL x 3.5 mmP |
D745701206IMP0012 | Glidewell IH™ Implant 3.7 mmD x 16 mmL x 3.5 mmP |
D745701206IMP0011 | Glidewell IH™ Implant 3.7 mmD x 13 mmL x 3.5 mmP |
D745701206IMP00100 | Glidewell IH™ Implant 3.7 mmD x 11.5 mmL x 3.5 mmP |
D745701206IMP00090 | Glidewell IH™ Implant 3.7 mmD x 10 mmL x 3.5 mmP |
D745701206IMP00080 | Glidewell IH™ Implant 3.7 mmD x 8 mmL x 3.5 mmP |
D745701206IMP00070 | Glidewell IH™ Implant 3.2 mmD x 16 mmL x 3.0 mmP |
D745701206IMP00060 | Glidewell IH™ Implant 3.2 mmD x 13 mmL x 3.0 mmP |
D745701206IMP00050 | Glidewell IH™ Implant 3.2 mmD x 11.5 mmL x 3.0 mmP |
D745701206IMP00040 | Glidewell IH™ Implant 3.2 mmD x 10 mmL x 3.0 mmP |
D745701206IMP00030 | Glidewell IH™ Implant 3.2 mmD x 8 mmL x 3.0 mmP |
D745701195PRC00040 | Glidewell IH™ Prosthetic Driver - 38 mm |
D745701195PRC00030 | Glidewell IH™ Prosthetic Driver - 30 mm |
D745701195PRC00020 | Glidewell IH™ Prosthetic Driver - 24 mm |
D745701195PRC00010 | Glidewell IH™ Prosthetic Driver - 18 mm |
D745701074PRS01050 | Glidewell IH™ Angled Multi-Unit Abutment Screw |
D745701074PRS01040 | Glidewell IH™ Multi-Unit Guide Pin .050" Hex |
D745701074PRS01030 | Glidewell IH™ Multi-Unit Driver |