FDA.reportPublic FDA data

TPC

Primary DI
D861A750LED0
Brand
TPC
Company
TPC ADVANCE TECHNOLOGY, INC.
Model
a750led
Catalog number
a750led
Device description
scaler with led to remove calculus
Published
2017-09-11
Public version status
Update
Distribution status
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
K051547000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051547000POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30Tpc Advanced Technology, Inc.2005-07-14ELC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D861A750LED0PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
968884275
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D861D650TPCD650ND6502018-08-22
D861A750N0TPCA750NA750N2017-09-11
D861A800LED0TPCa800leda800led2017-09-11
D861A800N0TPCa800na800n2017-09-11
D861A850LED0TPCA850LEDA850LED2017-09-11
D861ALED25000TPCALED2500ALED25002017-09-11
D861ALED500TPCALED50ALED502017-09-11
D861ALED55BN0TPCALED55BNALED55BN2017-09-11
D861ALED55N0TPCALED55NALED55N2017-09-11
D861ALED60N0TPCALED60NALED60N2017-09-11
D861ALED70N0TPCALED70NALED70N2017-09-11
D861LED39N0TPCALED39NALED39N2017-09-04
D861PL1000TPCPL100PL1002017-09-11
D861PL1500TPCPL150PL1502017-09-11
D861PM250TPCPM25PM252017-09-11

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
04560264548459Powder Handpiece(For Prophy use)NAKANISHI INC.ELC2026-06-11
04560264548473Powder Handpiece(For Perio use)NAKANISHI INC.ELC2026-06-11
04560264579538CLM Bottole SetNAKANISHI INC.ELC2026-06-11
04560264579569CLM HolderNAKANISHI INC.ELC2026-06-11
04589551391202Prophy Kit2NAKANISHI INC.ELC2026-06-11
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