Park Dental Research Corporation CASE-4

GUDID D769CASE40

Lew MDI Case

PARK DENTAL RESEARCH CORP

Surgical instrument/implant rack

• Primary Device ID: D769CASE40
• NIH Device Record Key: b86ba2d9-7d35-420c-93d1-173f0afba616
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Park Dental Research Corporation
• Version Model Number: CASE-4
• Catalog Number: CASE-4
• Company DUNS: 011441508
• Company Name: PARK DENTAL RESEARCH CORP
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: 1-800-243-7372
• Email: info@pdrus.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D769CASE40 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121707

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

[D769CASE40]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-14
• Device Publish Date: 2018-11-13

On-Brand Devices [Park Dental Research Corporation]

• D769XP50160: 5.0 mm x 16 mm XP StarVent Implant w/ Cover Screw
• D769XP50130: 5.0 mm x 13 mm XP StarVent Implant w/ Cover Screw
• D769XP50110: 5.0 mm x 11 mm XP StarVent Implant w/ Cover Screw
• D769XP50100: 5.0 mm x 10 mm XP StarVent Implant w/ Cover Screw
• D769XP50080: 5.0 mm x 08 mm XP StarVent Implant w/ Cover Screw
• D769XP42160: 4.2 mm x 16 mm XP StarVent Implant w/ Cover Screw
• D769XP42130: 4.2 mm x 13 mm XP StarVent Implant w/ Cover Screw
• D769XP42110: 4.2 mm x 11 mm XP StarVent Implant w/ Cover Screw
• D769XP42100: 4.2 mm x 10 mm XP StarVent Implant w/ Cover Screw
• D769XP42080: 4.2 mm x 08 mm XP StarVent Implant w/ Cover Screw
• D769XP38160: 3.75 mm x 16 mm XP StarVent Implant w/ Cover Screw
• D769XP38130: 3.75 mm x 13 mm XP StarVent Implant w/ Cover Screw
• D769XP38110: 3.75 mm x 11 mm XP StarVent Implant w/ Cover Screw
• D769XP38100: 3.75 mm x 10 mm XP StarVent Implant w/ Cover Screw
• D769XP38080: 3.75 mm x 08 mm XP StarVent Implant w/ Cover Screw
• D769XP33160: 3.3 mm x 16 mm XP StarVent Implant w/ Cover Screw
• D769XP33130: 3.3 mm x 13 mm XP StarVent Implant w/ Cover Screw
• D769CASE40: Lew MDI Case
• D769CASE30: Multi System Case
• D769BNC10: Bone Caliper