OrthoEasy®

GUDID EFOR129910031

Fixation screw for palatinal pin

Forestadent Bernhard Förster GmbH

Orthodontic appliance system, adjustable

• Primary Device ID: EFOR129910031
• NIH Device Record Key: 85bc08a6-06f7-4637-8337-7179bd4ce86d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoEasy®
• Version Model Number: 1299-1003
• Company DUNS: 316074384
• Company Name: Forestadent Bernhard Förster GmbH
• Device Count: 10
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4972314590
• Email: regulatory@forestadent.com
• Phone: +4972314590
• Email: regulatory@forestadent.com
• Phone: +4972314590
• Email: regulatory@forestadent.com
• Phone: +4972314590
• Email: regulatory@forestadent.com
• Phone: +4972314590
• Email: regulatory@forestadent.com
• Phone: +4972314590
• Email: regulatory@forestadent.com
• Phone: +4972314590
• Email: regulatory@forestadent.com
• Phone: +4972314590
• Email: regulatory@forestadent.com
• Phone: +4972314590
• Email: regulatory@forestadent.com
• Phone: +4972314590
• Email: regulatory@forestadent.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EFOR129910031 [Primary]
HIBCC	EFOR1299100311 [Unit of Use]

FDA Product Code

• NDP: Accessories, implant, dental, endosseous

Sterilization

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

[EFOR129910031]

Moist Heat or Steam Sterilization

[EFOR129910031]

Moist Heat or Steam Sterilization

[EFOR129910031]

Moist Heat or Steam Sterilization

[EFOR129910031]

Moist Heat or Steam Sterilization

[EFOR129910031]

Moist Heat or Steam Sterilization

[EFOR129910031]

Moist Heat or Steam Sterilization

[EFOR129910031]

Moist Heat or Steam Sterilization

[EFOR129910031]

Moist Heat or Steam Sterilization

[EFOR129910031]

Moist Heat or Steam Sterilization

[EFOR129910031]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-02
• Device Publish Date: 2019-09-24

On-Brand Devices [OrthoEasy®]

• EFOR129910061: OrthoEasy Pal Blade for Retaining Screw
• EFOR129910041: Palatal abutment
• EFOR129910031: Fixation screw for palatinal pin
• EFOR129900071: Manual driver with torque control limit 10 Ncm
• EFOR119910401: Ortho Easy pilot drill ø 1.0 x 4 mm
• EFOR119900151: Ortho Easy blade 45 mm octagonal f. screw driver
• EFOR119900081: Ortho Easy blade 10 mm octagonal f. angled hand piece
• EFOR119900071: Ortho Easy blade 5 mm octagonal f. angled hand piece
• EFOR119900061: Ortho Easy blade 10 mm octagonal f. screw driver
• EFOR119900021: Ortho Easy handle f. screw driver standard size
• EFOR119900001: Ortho Easy Rack (blank) f. implants and instruments
• EFOR1201A23081: Ortho Easy Palatinal Pin 8 x 1,7 mm
• EFOR1101A23101: Ortho Easy Pin gold anodized .022" 1,7 x 10 mm (5 pcs.)
• EFOR1101A23081: Ortho Easy Pin pink anodized .022" 1,7 x 8 mm (5 pcs.)
• EFOR1101A23061: Ortho Easy Pin rose anodized .022" 1,7 x 6 mm (5 pcs.)