DEVICE: J. MORITA MFG. CORP. (04548213055999)

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
J. MORITA MFG. CORP.
TR-ZX2 Type PLUS
In Commercial Distribution

J.MORITA MFG.CORP.
04548213055999
GS1

1
693811465 *Terms of Use
Revised version of TR-ZX2 from 2023.
CLOSE

Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
66245 Dental surgical power tool motorized handpiece/set, electric
An electrically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade] for drilling, cutting, polishing, and/or inserting procedures involving bones and tough tissues during a dental surgical procedure. It includes an electric motor and the appropriate attachments (e.g., angle adaptor, torque multiplier) at its distal end for connection of the endpieces and may include a rechargeable battery or a control unit; the endpieces are not included. This is a reusable device.
Active false
16355 Endodontic apex locator
A dental instrument, using electricity, designed to locate the top of the root canal during endodontic procedures. This is a reusable device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
EKX Handpiece, Direct Drive, Ac-Powered
LQY Locator, Root Apex
CLOSE

FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K170275 000
No CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status
7173d21b-def3-4748-91bf-1ee2a677d2ab
March 14, 2023
1
March 06, 2023
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE