OBI

Basic Information

• Brand Name: OBI
• Primary DI: 03700977511048
• Version / Model: Implant OBI ball 9mm
• Catalog Number: OIC_27.68.090
• Company Name: EUROTEKNIKA
• Labeler DUNS: 382690691
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-01
• Public Version: 1
• Public Version Date: 2018-11-01
• Public Version Status: New
• Public Device Record Key: fd64cdf3-e81e-4b3f-b389-b37450fab862

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DZE	Implant, Endosseous, Root-Form	Dental	872.3640	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55847	Dental implant system	A collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03700977511048	GS1

Premarket Submissions

Submission Number	Supplement Number
K083670	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store away from light Keep dry Do not use if packaging is damaged or opened