SmartPeg Type 98 - Neoss

Basic Information

• Brand Name: SmartPeg Type 98 - Neoss
• Primary DI: 09010522002070
• Version / Model: SmartPeg Type 98 - Neoss
• Catalog Number: 91073
• Company Name: Osstell AB
• Labeler DUNS: 633171269
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-14
• Public Version: 2
• Public Version Date: 2024-09-19
• Public Version Status: Update
• Public Device Record Key: 2f9f1851-1099-4bad-a02e-270592750b67

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: 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
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63468	Dental implant stability resonance frequency analysis peg	A small, 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 [typically referred to as resonance frequency analysis (RFA)]. 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
Primary	09010522002070	GS1

Premarket Submissions

Submission Number	Supplement Number
K181888	000