OrthoEasy®

GUDID EFOR1101A23081

Ortho Easy Pin pink anodized .022" 1,7 x 8 mm (5 pcs.)

Forestadent Bernhard Förster GmbH

Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw Orthodontic anchoring screw

• Primary Device ID: EFOR1101A23081
• NIH Device Record Key: 20bf0b02-140d-485f-8f85-f235082b8228
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoEasy®
• Version Model Number: 1101A2308
• 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	EFOR1101A23081 [Primary]
HIBCC	EFOR1101A230811 [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

[EFOR1101A23081]

Moist Heat or Steam Sterilization

[EFOR1101A23081]

Moist Heat or Steam Sterilization

[EFOR1101A23081]

Moist Heat or Steam Sterilization

[EFOR1101A23081]

Moist Heat or Steam Sterilization

[EFOR1101A23081]

Moist Heat or Steam Sterilization

[EFOR1101A23081]

Moist Heat or Steam Sterilization

[EFOR1101A23081]

Moist Heat or Steam Sterilization

[EFOR1101A23081]

Moist Heat or Steam Sterilization

[EFOR1101A23081]

Moist Heat or Steam Sterilization

[EFOR1101A23081]

Moist Heat or Steam Sterilization

[EFOR1101A23081]

Moist Heat or Steam Sterilization

[EFOR1101A23081]

Moist Heat or Steam Sterilization

[EFOR1101A23081]

Moist Heat or Steam Sterilization

[EFOR1101A23081]

Moist Heat or Steam Sterilization

[EFOR1101A23081]

Moist Heat or Steam Sterilization

[EFOR1101A23081]

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.)