FDA.reportPublic FDA data

Vector R&D, Inc

Primary DI
00810113691046
Brand
Vector R&D, Inc
Company
Vector R&D, Inc.
Model
10-HEL-E
Catalog number
10-HEL-E
Device description
Piezo Technologies Replacement Handpiece LED - EMS* Type
Published
2023-02-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELCScaler, ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELCScaler, UltrasonicDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040396000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040396000ULTRASONIC SCALER ELEGANCE MS-10 (25K)Rolence Enteprise, Inc.2004-04-22ELC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810113691046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810113691046008101136910468101136910460810113691046

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

Contacts#

Phone, Email table
PhoneEmail
+1(253)263-7208mattr@vectorusa.net

Regulatory Flags#

DUNS number
825399723
Device count
1
DM exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810113691152Vector R&D, IncEPS-UEPS-U2024-02-09
00810113691169Vector R&D, IncVx9-SSVx9-SS2024-02-09
00810113691176Vector R&D, IncVx9-SLSVx9-SLS2024-02-09
00810113691145Vector R&D, IncVM201LVM201L2023-03-08
00810113691015Vector R&D, IncTT-ECRATT-ECRA2023-02-07
00810113691022Vector R&D, IncMT-20PDXMT-20PDX2023-02-07
00810113691039Vector R&D, Inc10-HE10-HE2023-02-07
00810113691053Vector R&D, Inc10-HE-S10-HE-S2023-02-07
00810113691060Vector R&D, Inc10-HEL-S10-HEL-S2023-02-07
00810113691077Vector R&D, IncVM45LVM45L2023-02-07
00810113691084Vector R&D, IncVM20LP/KV68VM20LP/KV682023-02-07
00810113691091Vector R&D, IncVM10-SGVM10-SG2023-02-07
00810113691107Vector R&D, IncVM10L-SGVM10L-SG2023-02-07
00810113691114Vector R&D, IncVSSVSS2023-02-07
00810113691121Vector R&D, IncVSS5VSS52023-02-07
00810113691138Vector R&D, IncVSS6VSS62023-02-07
00810113690001Vector R&D, IncVx10-SLKVx10-SLK2022-09-30
00810113690018Vector R&D, IncVx10-SKVx10-SK2022-09-30
00810113690025Vector R&D, IncVx9-SLKVx9-SLK2022-09-30
00810113690032Vector R&D, IncVx9-SKVx9-SK2022-09-30

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