INTRA 181 K 20 000 R.P.M.

Basic Information

• Brand Name: INTRA 181 K 20 000 R.P.M.
• Primary DI: EKAV053552600
• Version / Model: 0.535.5260
• Catalog Number: 181 K 20 000 RPM
• Company Name: KaVo Dental GmbH
• Labeler DUNS: 333710619
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-26
• Public Version: 5
• Public Version Date: 2021-11-08
• Public Version Status: Update
• Public Device Record Key: b7045b51-7dea-4763-b416-a5c5331748f9

Device Description

This is a medical device.This is a medical device.

Device Characteristics

• Single Use: No
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
EFB	HANDPIECE, AIR-POWERED, DENTAL	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38763	Remotely-driven dental drilling system motor	A mains electricity (AC-powered) compact motor used in conjunction with a spinning cable (e.g., a Bowden cable) to provide remote rotational power from the motor to a dental drill handpiece. This device is line-powered and cannot be sterilized. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EKAV053552600	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K073478	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -20 – 70 Degrees Celsius