FDA.reportPublic FDA data

Lynx Scalemaster

Primary DI
D826LX3004H021
Brand
Lynx Scalemaster
Company
MTI Precision Products, LLC
Model
LX3004H02
Device description
The Lynx Scalemaster is an ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an sonic vibrating scaler tip to the teeth.
Published
2016-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ELCScaler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELCScaler, UltrasonicDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K901488000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K901488000LYNX-SM, SCLAER DENTAL HANDPIECEMti Precision Products1990-05-15ELC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D826LX3004H020Direct MarkingHIBCC0
D826LX3004H021PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rotary dental scalerAn abrasive device intended to be attached to a powered dental handpiece that provides rotation and is used to remove calculus deposits and other accretions from tooth surfaces during dental cleaning and periodontal (gum) therapy. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
081600128
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D8265007703LYNX MASTER CLASSIC M0TOR 50077-032023-02-10
D8265008703LYNX MASTER CLASSIC MOTOR50087-032023-02-10
D8265013503MASTER SWIVEL LYNX CLASSIC MOTOR50135032023-02-10
D8265013604MASTER TORQUEMASTER 550136042023-02-10
D8265015403MASTER PROPHY AIRLITE50154-032023-02-10
D8265015406MASTER PROPHY AIRLITE50154-062023-02-10
D8265015408MASTER PROPHY AIRLITE50154-082023-02-10
D8265016304MASTER PRO 550163-042023-02-10
D8265025003PROPHY AIRLITE 4-HOLE50250032023-02-10
D8265025006PROPHY AIRLITE 4-HOLE50250062023-02-10
D8265025008PHOPHY AIRLITE 4-HOLE50250082023-02-10
D826LX100B2LYNX CLASSIC MOTORLX100B2H2023-02-10
D826LX10104LYNX 4:1 REDUCTION CONTRA ANGLELX1012023-02-10
D826LX11SNCL03LYNX LONG BLUE NOSECONELX11SNCL2023-02-10
D826LX11SNCS03LYNX SHORT BLUE NOSECONELX11SNCS2023-02-10
D826LX14SNCL04LYNX 4:1 REDUCTION NOSECONELX14SNCL2023-02-10
D826LXPRO54LYNX PRO 5LXPRO5-4H2023-02-10
D826LXTM52TORQUEMASTER 5 2-HOLELXTM522023-02-10
D826LXTM54TORQUEMASTER 5 4-HOLELXTM542023-02-10
D826TM202TORQUEMASTER 20 2-HOLETM2022023-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07613353028374PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353170318PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353170325PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353223182PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353225117PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
J021304950011Foot control S-NW3W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021304970001Foot control S-N3W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305040001Implantmed Plus II (SI-2100)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305050001Implantmed Plus II (SI-2101)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305060001Implantmed Plus II (SI-2102)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305070001Piezomed Module Plus II (SP-210 M)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
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04589551391219Perio Kit2NAKANISHI INC.ELC2026-06-11
04589551395095Varios Combi Pro2 Basic SetNAKANISHI INC.ELC2026-06-11
04589551395323CLM Module SetNAKANISHI INC.ELC2026-06-11
04589551395347Water Bottle KitNAKANISHI INC.ELC2026-06-11
04589551395439FC-83NAKANISHI INC.ELC2026-06-11
04589551386758VA-SG-TIP HOLDERNAKANISHI INC.ELC2026-04-08