FDA.reportPublic FDA data

J. MORITA MFG. CORP.

Primary DI
04548213055999
Brand
J. MORITA MFG. CORP.
Company
J.MORITA MFG.CORP.
Model
TR-ZX2 Type PLUS
Device description
Revised version of TR-ZX2 from 2023. Brand name shall be Tri Auto ZX2.
Published
2023-03-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EKXHandpiece, Direct Drive, Ac-Powered
LQYLocator, Root Apex

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKXHandpiece, Direct Drive, Ac-PoweredDental1
LQYLocator, Root ApexUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170275000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170275000Tri Auto ZX2J. Morita USA, Inc.2017-09-11EKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04548213055999PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04548213055999045482130559994548213055999

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical power tool motorized handpiece/set, electricAn 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
693811465
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04548213056538Root ZX3RZX3 Type: RCM2023-06-27
04548213056545Root ZX3RZX3 Type: HF2023-06-27
04548213021260Spaceline EMCIACU-5802026-04-15
04548213015641Root ZX miniRCM-72026-04-07
04548213027408J. MORITA MFG. CORP.CA-5IF2023-02-01
04548213060153STERLINGBEN-4HEX-O-KV-452026-02-20
04548213060160STERLINGBEN-4HG-O-KV2026-02-20
04548213060177STERLINGBEN-4HG-O-NK2026-02-20
04548213057320TWINPOWER TURBINE 4HPAR-4HG-O2026-02-03
04548213057337TWINPOWER TURBINE 4HPAR-4HG-O-KV2026-02-03
04548213057344TWINPOWER TURBINE 4HPAR-4HG-O-NK2026-02-03
04548213057368TWINPOWER TURBINE 4HPAR-4HG-O-WH2026-02-03
04548213057375TWINPOWER TURBINE 4HPAR-4HG-O-SR2026-02-03
04548213745043Midwest 45 FBE NFO7450442023-08-18
04548213745241Midwest 45 K-Style NFO7452442023-08-18
04548213016556TORQTECHCA-5IF-O2022-12-19
00887919758013EndoSync A.I.RCM-75025412U02022-12-12
00887919832249EndoSync PLUSTR-CM5027135U02022-12-12
04548213008476N/ACP42022-12-12
04548213008483N/ACP4-O2022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10817417020227AsepticoASEPTICO, INC.EKX2026-04-08
10817417020326AsepticoASEPTICO, INC.EKX2026-04-08
10817417020371AsepticoASEPTICO, INC.EKX2026-04-06
10817417020388AsepticoASEPTICO, INC.EKX2026-04-06
10817417020418AsepticoASEPTICO, INC.EKX2026-04-03
10817417020425AsepticoASEPTICO, INC.EKX2026-04-03
10817417020432AsepticoASEPTICO, INC.EKX2026-04-03
10817417020449AsepticoASEPTICO, INC.EKX2026-04-03
08033837938316CEFLACEFLA SOCIETA' COOPERATIVALQY2026-03-31
08809260475458E-CUBESaeshin Precision Co., Ltd.EKX2026-03-31
10194665008444A-decA-DEC, INC.LQY2026-02-19
10194665008475A-decA-DEC, INC.EKX2026-02-19
10194665008475A-decA-DEC, INC.LQY2026-02-19
10194665008482A-decA-DEC, INC.EKX2026-02-19
10194665008482A-decA-DEC, INC.LQY2026-02-19
10194665008499A-decA-DEC, INC.LQY2026-02-19
10194665008499A-decA-DEC, INC.EKX2026-02-19
10194665008505A-decA-DEC, INC.EKX2026-02-19
10194665008505A-decA-DEC, INC.LQY2026-02-19
10194665008512A-decA-DEC, INC.EKX2026-02-19
10194665008512A-decA-DEC, INC.LQY2026-02-19
10194665008529A-decA-DEC, INC.LQY2026-02-19
10194665008529A-decA-DEC, INC.EKX2026-02-19
10194665008550A-decA-DEC, INC.LQY2026-02-19
10194665008550A-decA-DEC, INC.EKX2026-02-19
09010522002513SmartPeg Type 127Osstell ABEKX2026-02-09
09010522002537SmartPeg Type 137Osstell ABEKX2026-02-09
D100B00XSGO000000X-Smart Go Cordless endo motor with integrated apex locatorFORUM ENGINEERING TECHNOLOGIES (96) LTD.EKX2026-01-23