FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

K Number

K973800

Device Name

23:1 REDUCTION ANGLE

Manufacturer

MIDWEST DENTAL PRODUCTS CORP.

Date Cleared

1998-03-11

(156 days)

Product Code

EGS DAT

Regulation Number

872.4200

Intended Use

The Indications for Use of this device is to provide a dental professional a lowspeed handpiece which may be used, in conjunction with various dental burs as identified by the dental professional, in the performance of various dental procedures including, but not limited to, Prophy, Post and Pin Drilling, Pin Setting, Root Canal Enlargement and Sealing, and Caries Removal. The intended patient population is the general population requiring such procedures.

Device Description

Not Found

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K Number

K964755

Device Name

MICROJET CAVITY PREPARATION SYSTEM

Manufacturer

MIDWEST DENTAL PRODUCTS CORP.

Date Cleared

1997-09-11

(288 days)

Product Code

KOJ DAT

Regulation Number

872.6080

Intended Use

MicroJet System is an AC-powered cavity preparation device. The device uses air-driven particles to roughen the surfaces of dental restorations. MicroJet System is intended as an ancillary device for removing tooth structure, and restorative dental materials as well as preparing teeth for dental restoration.

Device Description

MicroJet System is an AC-powered cavity preparation device. The device uses air-driven particles to roughen the surfaces of dental restorations.

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K Number

K962877

Device Name

MIDWEST 300 SE

Manufacturer

MIDWEST DENTAL PRODUCTS CORP.

Date Cleared

1996-10-18