Sculpt I.Q. 6659291G

GUDID D8076659291G1

EasyTip Endo Pack 25

DENTSPLY SIRONA ORTHODONTICS INC.

Dental diode laser system

• Primary Device ID: D8076659291G1
• NIH Device Record Key: 7235b21e-7c1e-4399-ba0a-d860f55e36ae
• Commercial Distribution Discontinuation: 2018-04-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Sculpt I.Q.
• Version Model Number: 6659291G
• Catalog Number: 6659291G
• Company DUNS: 116903307
• Company Name: DENTSPLY SIRONA ORTHODONTICS INC.
• Device Count: 25
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)883-8733
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(800)883-8733
• Email: CustomerService_GAC@dentsplysirona.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8076659291G0 [Unit of Use]
HIBCC	D8076659291G1 [Primary]

FDA Product Code

• ILY: Lamp, infrared, therapeutic heating

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-07
• Device Publish Date: 2018-03-14

On-Brand Devices [Sculpt I.Q.]

• 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)