Osstell SmartPeg Type 09

Basic Information

• Brand Name: Osstell SmartPeg Type 09
• Primary DI: 09010522001240
• Version / Model: Osstell SmartPeg Type 09
• Catalog Number: 100368
• Company Name: Osstell AB
• Labeler DUNS: 633171269
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-02
• Public Version: 1
• Public Version Date: 2022-09-12
• Public Version Status: New
• Public Device Record Key: 3b1bcb30-4ce9-4236-961e-4ef362c71b3e

Device Description

ISQ Measurement Peg

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: No
• 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
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63468	Dental implant stability measurement peg	A small, sterile, screw-like device intended to be attached to a dental implant or abutment to measure the stability of the implant. It is used with a control unit (not included) which provides an electromagnetic pulsation to create a noninvasive vibrating force in the peg, and the subsequent degree of peg movement provides a measure of dental implant stability. This measurement can be repeated over time to help assess the progress of implant osseointegration. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	09010522000106	GS1	Box	5	In Commercial Distribution
Primary	09010522001240	GS1