MECTRON - R1 is an endodontic insert to be used in - MECTRON SPA

Duns Number:436664734

Device Description: R1 is an endodontic insert to be used in conjunction with Mectron scaler handpieces. The p R1 is an endodontic insert to be used in conjunction with Mectron scaler handpieces. The package includes insert and K10 torque wrench (DI Number E32202900137).

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More Product Details

Catalog Number

03050001-001

Brand Name

MECTRON

Version/Model Number

R1 + K10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K140965

Product Code Details

Product Code

ELC

Product Code Name

Scaler, Ultrasonic

Device Record Status

Public Device Record Key

ea0d7dc8-022b-4323-adaf-024b85e6ba3c

Public Version Date

September 19, 2019

Public Version Number

1

DI Record Publish Date

September 11, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MECTRON SPA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 45
2 A medical device with a moderate to high risk that requires special controls. 199