Park Dental Research Corp.

Basic Information

• Brand Name: Park Dental Research Corp.
• Primary DI: D769OMHP20
• Version / Model: OMHP-2
• Company Name: PARK DENTAL RESEARCH CORP
• Labeler DUNS: 011441508
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-01-29
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 79a88039-00e6-488b-807e-20e8a7a1b72a

Device Description

Metal Housing Pink Single Pack

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: No

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
46307	Dental anchor	A device made of austenitic alloys or alloys containing 75 percent or greater gold (Au) or metals of the platinum group, intended to be incorporated into a dental appliance, such as a denture, to help stabilize the appliance in the patient's mouth.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D769OMHP20	HIBCC

Customer Contacts

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