Primary Device ID | D8076659200G1 |
NIH Device Record Key | c830ec02-ae74-459c-b6f6-421dbdc290f0 |
Commercial Distribution Discontinuation | 2018-04-09 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | Sculpt I.Q. |
Version Model Number | 6659200G |
Catalog Number | 6659200G |
Company DUNS | 116903307 |
Company Name | DENTSPLY SIRONA ORTHODONTICS INC. |
Device Count | 1 |
DM Exempt | true |
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 | false |
Manufacturing Date | false |
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 | D8076659200G1 [Primary] |
GEX | Powered laser surgical instrument |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2020-02-07 |
Device Publish Date | 2018-03-14 |
D8076661420G1 | Upgrade Package, 660nm wavelength |
D8076659556G1 | Wireless Foot Control |
D8076659309G1 | MultiTip 8mm, therapy light guide |
D8076659291G1 | EasyTip Endo Pack 25 |
D8076659283G1 | EasyTip 320 Pack 25 |
D8076659242G1 | Laser protective goggle for patient |
D8076659234G1 | Laser protective goggles for spectacle wearers |
D8076659226G1 | Laser protective goggles |
D8076659218G1 | Fibercutter |
D8076659200G1 | EasyBend - Bending tool |
D8076659192G1 | Optic protection cap for handpiece (5 pieces) |
D8076659184G1 | Handpiece sleeve with keypad |
D8076659101G1 | Sculpt I.Q. Laser, USA |
D74666592831 | EasyTip 320 Pack 25 |
D74666592341 | Laser protective goggles for spectacle wearers |
D74666592261 | Laser protective goggles |
D74666591841 | Handpiece sleeve with keypad |
D74666595561 | Wireless Foot Control |
D74666592911 | EasyTip Endo Pack 25 |
D74666592181 | Fibercutter |
D74666592001 | EasyBend - Bending tool |
D74666593091 | MultiTip 8mm, therapy light guide |
D74666591011 | Sculpt I.Q. Laser, USA |
D74666591921 | Optic protection cap for handpiece (5 pieces) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SCULPT I.Q. 87807085 5735042 Live/Registered |
DENTSPLY SIRONA Inc. 2018-02-22 |