OP OPS3013

GUDID D742OPS30130

One Piece™ Slim Implant Ø3.0 X 13mm

INTRA-LOCK INTERNATIONAL, INC.

Dental implant system

• Primary Device ID: D742OPS30130
• NIH Device Record Key: 122add02-d206-4178-b7e0-7c20446a513e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OP
• Version Model Number: OPS3013
• Catalog Number: OPS3013
• Company DUNS: 131500998
• Company Name: INTRA-LOCK INTERNATIONAL, INC.
• Device Count: 1
• 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: false
• 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: 8773300338
• Email: info@intra-lock.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D742OPS30130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130140

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-06-11

On-Brand Devices [OP]

• D742OPHC20: Healing Cap IOPA/SOPA Abut.
• D742OPS30150: One Piece™ Slim Implant Ø3.0 X 15mm
• D742OPS30130: One Piece™ Slim Implant Ø3.0 X 13mm
• D742OPS30110: One Piece™ Slim Implant Ø3.0 X 11.5mm
• D742OPS30100: One Piece™ Slim Implant Ø3.0 X 10mm