IMTEC XP3813

GUDID D769IMXP38130

XP StarVent Implant w/ Cover Screw

PARK DENTAL RESEARCH CORP

Screw endosteal dental implant, two-piece

• Primary Device ID: D769IMXP38130
• NIH Device Record Key: 318b28e0-7986-4cb5-b25c-44db5e21020d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMTEC
• Version Model Number: IM-XP3813
• Catalog Number: XP3813
• Company DUNS: 011441508
• Company Name: PARK DENTAL RESEARCH CORP
• Device Count: 1
• DM Exempt: true
• 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: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com
• Phone: 1-800-243-7372
• Email: info@pdrus.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D769IMXP38130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082800

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-28
• Device Publish Date: 2024-08-20

On-Brand Devices [IMTEC ]

• D769MH340: Metal Housing Small (4 Pack)
• D769MH30: Metal Housing Small (Single Pack)
• D769MH240: Metal Housing Medium (4 Pack)
• D769MH20: Metal Housing Medium (Single Pack)
• D769MH140: Metal Housing Large (4 Pack)
• D769MH10: Metal Housing Large (Single Pack)
• D769LAXO0: Implant Analog Non-Collared
• D769LACO0: Implant Analog Collared
• D76910030: Tissue Marker
• D76901650: Finger Driver (18 mm Length)
• D769CASE60: IMTEC Autoclavable Instrument Cassette
• D76990320: Winged Thumb Wrench
• D76980400: Torque Wrench (15-80 Ncm)
• D76910120: 1.2 mm Drill
• D76910100: Undercut Blocking Shims
• D7690550250: Large O-Rings (25 Pack)
• D7690550100: Large O-Ring (10 Pack)
• D7690350250: Small/Medium O-Rings (25 Pack)
• D7690350100: Small/Medium O-Rings (10 Pack)
• D76903000: 3.0 mm Site Punch
• D76902500: 2.5 mm Site Punch
• D76902000: 2.0 mm Site Punch
• D7690165L0: Finger Driver Long (28 mm Length)
• D7693017MOB0: 3.0 mm x 17 mm Max O-Ball Implant
• D7693016MOB0: 3.0 mm x 16 mm Max O-Ball Implant
• D7693015MOB0: 3.0 mm x 15 mm Max O-Ball Implant
• D7693014MOB0: 3.0 mm x 14 mm Max O-Ball Implant
• D7693013MOB0: 3.0 mm x 13 mm Max O-Ball Implant
• D7693012MOB0: 3.0 mm x 12 mm Max O-Ball Implant
• D7693010MOB0: 3.0 mm x 10 mm Max O-Ball Implant
• D7691816XO0: 2.0 mm x 16 mm Non-Collared Implant
• D7691816CO0: 2.0 mm x 16 mm Collared Implant
• D7691814XO0: 2.0 mm x 14 mm Non-Collared Implant
• D7691812XO0: 2.0 mm x 12 mm Non-Collared Implant
• D7691812CO0: 2.0 mm x 12 mm Collared Implant
• D7691810XO0: 2.0 mm x 10 mm Non-Collared Implant
• D7691810CO0: 2.0 mm x 10 mm Collared Implant
• D76910250: 2.5 mm Drill
• D76910200: 2.0 mm Drill
• D76910150: 1.5 mm Drill
• D7692717MOB0: 2.75mm x 17 mm MAX O-Ball Implant
• D7692716MOB0: 2.75 mm x 16mm MAX O-Ball Implant
• D7692715MOB0: 2.75 mm x 15 mm MAX O-Ball Implant
• D7692714MOB0: 2.75 mm x 14 mm MAX O-Ball Implant
• D7692713MOB130: 2.75 mm x 13 mm MAX O-Ball Implant
• D7692712MOB0: 2.75 mm x 12 mm MAX O-Ball Implant
• D7692711MOB0: 2.75 mm x 11 mm MAX O-Ball Implant
• D7692710MOB0: 2.75 mm x 10 mm MAX O-Ball Implant
• D7692217MOB0: 2.25 mm x 17 mm MAX O-Ball Implant
• D7692216MOB0: 2.25 mm x 16 mm MAX O-Ball Implant