Twist™ plus Oscillating Disposable Prophy Angles

GUDID 00732224000084

Prophy Angles Tapered Brush

CROSSTEX INTERNATIONAL, INC.

Dental-professional prophylaxis brush, single-use Dental-professional prophylaxis brush, single-use Dental-professional prophylaxis brush, single-use Dental-professional prophylaxis brush, single-use Dental-professional prophylaxis brush, single-use Dental-professional prophylaxis brush, single-use Dental-professional prophylaxis brush, single-use Dental-professional prophylaxis brush, single-use Dental-professional prophylaxis brush, single-use Dental-professional prophylaxis brush, single-use Dental-professional prophylaxis brush, single-use Dental-professional prophylaxis brush, single-use Dental-professional prophylaxis brush, single-use Dental-professional prophylaxis brush, single-use Dental-professional prophylaxis brush, single-use Dental-professional prophylaxis brush, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use

• Primary Device ID: 00732224000084
• NIH Device Record Key: 344efd37-7c6e-4fb9-a36e-251555bb0130
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Twist™ plus Oscillating Disposable Prophy Angles
• Version Model Number: TPLUSPATB
• Company DUNS: 057728685
• Company Name: CROSSTEX INTERNATIONAL, INC.
• Device Count: 100
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00732224000084 [Unit of Use]
GS1	10732224000081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030603
• Premarket Notification: K973062

FDA Product Code

• EFA: Handpiece, belt and/or gear driven, dental
• EGS: Handpiece, contra- and right-angle attachment, dental

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-07
• Device Publish Date: 2022-09-29

On-Brand Devices [Twist™ plus Oscillating Disposable Prophy Angles]

• 00732224000084: Prophy Angles Tapered Brush
• 00732224000077: Prophy Angles,Firm cup, White
• 00732224000060: Prophy Angles,Soft cup, Gray