ORA Complete Attachment

Basic Information

• Brand Name: ORA Complete Attachment
• Primary DI: 00841549113208
• Version / Model: 904700
• Company Name: STERNGOLD DENTAL LLC
• Labeler DUNS: 124763728
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-01
• Public Version: 7
• Public Version Date: 2023-03-24
• Public Version Status: Update
• Public Device Record Key: 3dfd5fcd-d4a0-468d-915a-5c228ad3b8db

Device Description

1 plastic ORA male Pattern, 1 gold plated closed retaining cap and 1 white block-out spacer. The ORA Implant Abutment System is a precision machined ball shaped abutment that connects a compatible dental implant system with a removable partial or complete overdenture. The implant abutment is screwed into the dental implant. Connection to and retention of a denture is provided by a rubber o-ring, which may or may not be held within a metal housing. There are two color o-rings, a red processing o-ring and a white final o-ring. Connection and retention may also be provided by a plastic keeper that is processed into the denture.

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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
NHA	Abutment, Implant, Dental, Endosseous	Dental	872.3630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38603	Resilient dental precision attachment	A dental fixation device designed to give a tooth-borne/tissue-borne prosthesis sufficient mechanical play to withstand the variations in the seating of the prosthesis due to deformation of the underlying tissues, without placing excessive stress on the abutments.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841549113208	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K133791	000