IMTEC

Basic Information

• Brand Name: IMTEC
• Primary DI: D769IMSVKITMT0
• Version / Model: IM-SVKIT-MT
• Catalog Number: SVKIT-MT
• Company Name: PARK DENTAL RESEARCH CORP
• Labeler DUNS: 011441508
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-20
• Public Version: 3
• Public Version Date: 2026-04-30
• Public Version Status: Update
• Public Device Record Key: 9516ae27-f267-4d7d-9546-63b6c43510e6
• Distribution End Date: 2026-04-30

Device Description

StarVent MT Surgical Kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NDP	Accessories, Implant, Dental, Endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45147	Dental/maxillofacial surgical procedure kit, non-medicated, reusable	A collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D769IMSVKITMT0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]