OrthoEasy®

GUDID EFOR1201A23081

Ortho Easy Palatinal Pin 8 x 1,7 mm

Forestadent Bernhard Förster GmbH

Orthodontic anchoring screw

• Primary Device ID: EFOR1201A23081
• NIH Device Record Key: fe7f5775-5a5a-45cd-9ef8-62f983ccba53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoEasy®
• Version Model Number: 1201A2308
• Company DUNS: 316074384
• Company Name: Forestadent Bernhard Förster GmbH
• Device Count: 5
• DM Exempt: false
• 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: 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
• 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	EFOR1201A23081 [Primary]
HIBCC	EFOR1201A230811 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110275

FDA Product Code

• OAT: Implant, endosseous, orthodontic

Sterilization

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

[EFOR1201A23081]

Moist Heat or Steam Sterilization

[EFOR1201A23081]

Moist Heat or Steam Sterilization

[EFOR1201A23081]

Moist Heat or Steam Sterilization

[EFOR1201A23081]

Moist Heat or Steam Sterilization

[EFOR1201A23081]

Moist Heat or Steam Sterilization

[EFOR1201A23081]

Moist Heat or Steam Sterilization

[EFOR1201A23081]

Moist Heat or Steam Sterilization

[EFOR1201A23081]

Moist Heat or Steam Sterilization

[EFOR1201A23081]

Moist Heat or Steam Sterilization

[EFOR1201A23081]

Moist Heat or Steam Sterilization

[EFOR1201A23081]

Moist Heat or Steam Sterilization

[EFOR1201A23081]

Moist Heat or Steam Sterilization

[EFOR1201A23081]

Moist Heat or Steam Sterilization

[EFOR1201A23081]

Moist Heat or Steam Sterilization

[EFOR1201A23081]

Moist Heat or Steam Sterilization

[EFOR1201A23081]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-08-23
• Device Publish Date: 2019-08-15

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.)