Park Dental Research Corp.

Basic Information

• Brand Name: Park Dental Research Corp.
• Primary DI: D769OIC10
• Version / Model: OIC-1
• 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: 2024-05-06
• Public Version: 2
• Public Version Date: 2025-03-07
• Public Version Status: Update
• Public Device Record Key: 05c5ced6-4490-49c6-8f00-93ff1b17cd9c
• Distribution End Date: 2025-03-06

Device Description

Impression Cap

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
64323	Dental implant abutment impression cap	A small device intended to be placed intraorally on the abutment head of a dental implant during a dental impression to facilitate removal of the impression material once it has hardened, and to reproduce the intraoral position and orientation of the abutment/implant in a dental laboratory working model, for the fabrication of a final dental prosthesis (e.g., denture). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D769OIC10	HIBCC

Customer Contacts

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