Park Dental Research Corp.

GUDID D769STAR1108U0

Startanius Narrow Ridge Implant Universal 8mm

PARK DENTAL RESEARCH CORP

Blade endosteal dental implant, two-piece

• Primary Device ID: D769STAR1108U0
• NIH Device Record Key: 31b0c80c-0e97-45c1-a65b-a2af12dff562
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Park Dental Research Corp.
• Version Model Number: STAR1108-U
• 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: 800-243-7372
• Email: info@pdrus.com
• Phone: 800-243-7372
• Email: info@pdrus.com
• Phone: 800-243-7372
• Email: info@pdrus.com
• Phone: 800-243-7372
• Email: info@pdrus.com
• Phone: 800-243-7372
• Email: info@pdrus.com
• Phone: 800-243-7372
• Email: info@pdrus.com
• Phone: 800-243-7372
• Email: info@pdrus.com
• Phone: 800-243-7372
• Email: info@pdrus.com
• Phone: 800-243-7372
• Email: info@pdrus.com
• Phone: 800-243-7372
• Email: info@pdrus.com
• Phone: 800-243-7372
• Email: info@pdrus.com
• Phone: 800-243-7372
• Email: info@pdrus.com
• Phone: 800-243-7372
• Email: info@pdrus.com
• Phone: 800-243-7372
• Email: info@pdrus.com
• Phone: 800-243-7372
• Email: info@pdrus.com
• Phone: 800-243-7372
• Email: info@pdrus.com
• Phone: 800-243-7372
• Email: info@pdrus.com
• Phone: 800-243-7372
• Email: info@pdrus.com
• Phone: 800-243-7372
• Email: info@pdrus.com
• Phone: 800-243-7372
• Email: info@pdrus.com
• Phone: 800-243-7372
• Email: info@pdrus.com
• Phone: 800-243-7372
• Email: info@pdrus.com
• Phone: 800-243-7372
• Email: info@pdrus.com
• Phone: 800-243-7372
• Email: info@pdrus.com
• Phone: 800-243-7372
• Email: info@pdrus.com
• Phone: 800-243-7372
• Email: info@pdrus.com
• Phone: 800-243-7372
• Email: info@pdrus.com
• Phone: 800-243-7372
• Email: info@pdrus.com
• Phone: 800-243-7372
• Email: info@pdrus.com
• Phone: 800-243-7372
• Email: info@pdrus.com
• Phone: 800-243-7372
• Email: info@pdrus.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D769STAR1108U0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K854749

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: 2024-05-16
• Device Publish Date: 2024-05-08

On-Brand Devices [Park Dental Research Corp.]

• D769P90510: 5.0mm Depth Gauge
• D769XP33110: StarVent XP 3.3 x 11 mm Internal Hex Implant w/ Cover Screw
• D769XP33100: StarVent XP 3.3 x 10 mm Internal Hex Implant w/ Cover Screw
• D769XP33080: StarVent XP 3.3 x 08 mm Internal Hex Implant w/ Cover Screw
• D769TP400: 4.0mm StarVent Tissue Punch
• D769TP350: 3.5mm StarVent Tissue Punch
• D769TP300: 3.0mm StarVent Tissue Punch
• D769TP250: 2.5mm Tissue Punch
• D769TP200: 2.0mm Tissue Punch
• D769TP150: 1.5mm Tissue Punch
• D769SVKITXP0: StarVent XP Surgical Kit
• D769SVKITMT0: StarVent MT Surgical Kit
• D769SVKIT10: Surgical Kit
• D769P9025S0: Abutment Driver Short
• D769P9025L0: Abutment Driver Long
• D769P50160: 5.0 mm x 16 mm StarVent Implant with cover screw and implant driver short
• D769P50130: 5.0 mm x 13 mm StarVent Implant with Cover Screw
• D769P50110: 5.0 mm x 11.5 mm StarVent Implant with cover screw
• D769P50100: 5.0 mm x 10 mm StarVent implant with cover screw
• D769P50080: 5.0 mm x 8 mm StarVent Implant with cover screw
• D769P43130: 4.2 mm x 13 mm StarVent implant with cover screw
• D769P42160: 4.2 mm x 16 mm StarVent Implant with cover screw
• D769P42110: 4.2 mm x 11.5 mm StarVent Implant with cover screw and implant driver
• D769P42100: 4.2 mm x 10 mm StarVent Implant with cover screw
• D769P42080: 4.2 mm x 8 mm StarVent Implant with cover screw and implant driver short
• D769P38160: 3.75 mm x 16 mm StarVent Implant with cover screw
• D769P38130: 3.75 mm x 13 mm StarVent Implant with Cover Screw
• D769P38110: 3.75 mm x 11.5 mm StarVent Implant with cover screw
• D769P38100: 3.75 mm x 10 mm StarVent implant with cover and implant driver short
• D769P38080: 3.75 mm x 8 mm StarVent implant with cover screw
• D769P33160: 3.3 mm x 16 mm StarVent Implant with Cover Screw
• D769P33100: 3.3 mm x 10 mm StarVent Implant with cover and implant short driver
• D769P33080: 3.3 mm x 8 mm StarVent Implant with cover screw and implant driver short
• D769P17420: 4.2mm Irrigated Drill (Outer Ø 3.75)
• D769P17370: 3.75mm Irrigated Drill (Outer Ø 3.25mm)
• D769P17200: 2.0mm Drill (non-irrigated) (outer Ø 2.0mm)
• D769OXAN20: Analog Non-Collared
• D769OR225: O-Ring Micro (25 pack)
• D769OR210: O-Ring Micro (10 pack)
• D769OR1100: O-Ring Large (10 pack)
• D769OMHP340: Metal Housing Pink 4 Pack
• D769OMHP30: Metal Housing Pink Single Pack
• D769OMHP240: Metal Housing Pink 4 Pack
• D769OMHP20: Metal Housing Pink Single Pack
• D769OMHP140: Metal Housing Pink 4 Pack
• D769OMHP10: Metal Housing Pink Large Single Pack
• D769OKIT10: Surgical Kit
• D769OCAN20: Analog Collared
• D769NRP10: NRpiezo + LED Narrow Ridge Piezo Surgical Unit w/LED
• D769MARK10: Surgical Marker