FDA.reportPublic FDA data

Ti-Max

Primary DI
04560224990137
Brand
Ti-Max
Company
NAKANISHI INC.
Model
S950BL
Published
2016-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ELCScaler, ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELCScaler, UltrasonicDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991021000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991021000SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NLNsk Nakanishi, Inc.1999-06-23ELC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560224990137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560224990137045602249901374560224990137

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic dental scaling/debridement system handpieceA holder for a detachable tip that functions as part of a pneumatic dental scaling/debridement system, designed to use compressed air to generate a vibrating action at the tip to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or 2) remove accretions from tooth surfaces during dental cleaning/periodontal therapy. Water is also fed through the handpiece and attached tip to assist in the process. It is typically designed with a standard 2-, 3-, or 4-hole connector utilizing the same connection to existing air-driven handpiece tubing and the water spray for lavage. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
690710546
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04589551388899VA170LUXS10VA170LUXS102026-10-06
04560264508422VA-SG-SCVA-SG-SC2026-10-05
04560264501911VA750LUX-SCVA750LUX-SC2026-10-01
04560264501935VA750-SCVA750-SC2026-10-01
04560264501942VA-SCVA-SC2026-10-01
04560264501980Water Filter Set (2m)Water Filter Set (2m)2026-10-01
04560264503649VA560LUX-SCVA560LUX-SC2026-10-01
04560264519022VA970-SCVA970-SC2026-10-01
04560264519039VA970LUX-SCVA970LUX-SC2026-10-01
04560264522510VA570-SCVA570-SC2026-10-01
04560264522527VA570LUX-SCVA570LUX-SC2026-10-01
04560264535213Water Filter Set (4m)Water Filter Set (4m)2026-10-01
04589551386765FC-15FC-152023-06-05
04560264522336Torque CalibratorTorque Calibrator2020-11-20
04560264566453NLZNLZ CDE2020-07-07
04560264565845TI-MAX X CONTRA/HPX95L2020-06-12
04560264565869TI-MAX X CONTRA/HPX25L2020-06-12
04560264565876TI-MAX X CONTRA/HPX20L2020-06-12
04560264565883TI-MAX X CONTRA/HPX15L2020-06-12
04560264565906TI-MAX X CONTRA/HPX952020-06-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04589551388899VA170LUXS10NAKANISHI INC.ELC2026-10-06
04560264508422VA-SG-SCNAKANISHI INC.ELC2026-10-05
04560264501911VA750LUX-SCNAKANISHI INC.ELC2026-10-01
04560264501935VA750-SCNAKANISHI INC.ELC2026-10-01
04560264501942VA-SCNAKANISHI INC.ELC2026-10-01
04560264501980Water Filter Set (2m)NAKANISHI INC.ELC2026-10-01
04560264503649VA560LUX-SCNAKANISHI INC.ELC2026-10-01
04560264519022VA970-SCNAKANISHI INC.ELC2026-10-01
04560264519039VA970LUX-SCNAKANISHI INC.ELC2026-10-01
04560264522510VA570-SCNAKANISHI INC.ELC2026-10-01
04560264522527VA570LUX-SCNAKANISHI INC.ELC2026-10-01
04560264535213Water Filter Set (4m)NAKANISHI INC.ELC2026-10-01
06979865810038JAS MotorDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810045JAS FillDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810052JAS PexDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810069JAS ActivatorDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810076JAS Charging UnitDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810083JAS Contra-AngleDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810090JAS Power SupplyDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810106JAS Activator Ultrasonic TipsDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810113JAS Fill Gutta-Percha NeedlesDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810175JAS Unit Endo SystemDENJOY DENTAL CO.,LTDELC2026-09-24
07613353194963PIEZON Handpiece S5E.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353240950PIEZON Handpiece LEDE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353257743AIR-FLOW-PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353311803Instrument PI starter kitE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353318123GBT Machine Wireless PedalE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353318581AIRFLOW Prophylaxis MasterE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353334833GBT Machine AIRFLOW Prophylaxis MasterE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353343408PIEZON Handpiece LEDE.M.S. Electro Medical Systems S.A.ELC2026-07-14