Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002105090

FEI Number

3002105090

Entity Name

SABLE INDUSTRIES, INC.

City/State/Country

Kitchener Ontario, CA

Establishment Address

100 Campbell Avenue, Suite 5, Kitchener Ontario N2H 4X8, CA

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Sable Industries, Inc. (Owner Number: 10024322)

Owner / Operator Contact Address

100 Campbell Avenue, Suite 5, Kitchener, CA-ON N2H 4X8, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TDC 6500 TDC 4500 Rotamax S6500KL Access S4500KL HVE/SE Valve (Suction) FDA Product Code EFB: Sable IS-205 Type 22K 4-Hole Motors w/ Internal A/W FDA Product Code EFB: Slow Speed & Premium Slow Speed Heads Ball Bearing Push Button FDA Product Code EGS: Premium Slow Speed Contra-Angles 1:1 Fiber Optic Ball Bearing w/ Internal Air & Water FDA Product Code EFB: Slow Speed & Premium Slow Speed Heads Ball Bearing Switch Latch FDA Product Code EFB: Sable NAC Type Standard Swing Latch-Heads FDA Product Code EFB: Premium Slow Speed Straight Nosecones 1:1 Ball Bearing w/ Internal Air & Water FDA Product Code EGS: Premium Slow Speed Contra-Angles 1:1 Ball Bearing w/ Internal Air & Water FDA Product Code EGS: Sable EC Type 1:1 12-Tooth Contra-Angle FDA Product Code EFB: Premium Slow Speed 20K Air Motors w/ Internal Air & Water FDA Product Code EFB: Sable NSK Type Ball-Bearing Auto Latch-Heads FDA Product Code EFB: Straight air hoses: Type B FDA Product Code EFB: Sable EX-203 Type 22K 4-Hole Air Motors FDA Product Code EGS: Sable Kavo Type 1:1 Contra-Angle w/ Internal A/W FDA Product Code EFB: Sable Kavo Type 1:1 Ball-Bearing Auto Latch-Heads FDA Product Code EFB: Sable Kavo Type 1:1 Straight Attachments w/ Internal A/W FDA Product Code EFB: Sable EX-6 Type 1:1 Straight Attachments FDA Product Code EFB: Electronic fiber optic control board FDA Product Code EGS: Sable E-Type 1:1 Ball-Bearing Auto-Latch Contra-Angle P/N 1600214 FDA Product Code EGS: Sable E-Type 4:1 Screw-In Prophy Contra-Angle P/N 1600216 FDA Product Code EGS: Sable E-Type 1:1 Ball-Bearing PB FG Contra-Angle P/N 1600215 FDA Product Code EGS: Sable E-Type 4:1 Snap-On Prophy Contra-Angle P/N 1600217 FDA Product Code EGS: Sable E-Type 4:1 Auto-Latch Contra-Angle P/N 1600218 Sable 4:1 Straight Attachments Access Pro NL - 2000017 Rotamax Pro NL - 2000018 Rotamax Pro KL - 2000019 Access Pro KL - 2000020 S600NL NLC400 S700NL Air/Water Syringe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2011-05-15
EBR	Unit, Suction Operatory	Dental	Class 1	872.6640	2023-05-24
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2016-04-18
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2016-04-18
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2018-01-18
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2010-08-24
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2023-05-24

Official Correspondent

Jeff DaSilva

US Agent Details

Kevin Randall Business: ComplianceAcuity, Inc Email: info@complianceacuity.com Phone: (303) 8280844

Related Public Records

Same Entity

Sable Industries, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K212910	Shenzhen Carejoy Technology Co., Ltd.	Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece	2022-11-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002105090. Last updated year: 2026. Please use registration number 3002105090 when referencing this establishment in official correspondence.