Registered with FDA

E/T Endodontic Technologies, Ltd.

HALIFAX, NOVA SCOTIA, Canada. Lists 14 dental device types with FDA across 1 registered establishment.

FDA owner/operator9063656Foreign exporterRepacker / relabeler
Device types listed
14
Brands and models
13
510(k) clearances
0as applicant
Markets registered in
212 registrations outside the US
Establishments
1Canada

Registered in 2 markets

Where regulators' registries name E/T Endodontic Technologies, Ltd. as the manufacturer or the registration holder of a device.

All markets
United States: 14 device types listedCanada: 12 registrations
RegisteredHome: CanadaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAListerE/T Endodontic Technologies, Ltd.14 device types—Below
CanadaHealth CanadaRegistration holderE/T ENDODONTIC TECHNOLOGIES INC.122006–2026Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What E/T Endodontic Technologies, Ltd. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Intraoral Dental DrillDZA · Class 1Surgical drills & motorsLister
MANI Gates Drills
2011
Dental Diamond InstrumentDZP · Class 1Dental burs & diamondsLister
MANI Dia-Burs
2011
Mouth MirrorEAX · Class 1Dental hand instrumentsLister—2025
Rubber DamEIE · Class 1Rubber dam systemsLister
ISOLATE PREMIUM DENTAL DAM
2006
Calcium Hydroxide Cavity LinerEJK · Class 2—Lister
Multi-Cal
2010
Dental BurEJL · Class 1Dental burs & diamondsLister—2025
Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1Dental hand instrumentsLister
MANI Finger Spreaders
2011
Endodontic Pulp Canal ReamerEKP · Class 1Endodontic filesLister
MANI Reamers
2011
Root Canal Endodontic PreparerEKQ · Class 1Endodontic filesLister
CHELATE
2004
Endodontic Root Canal PluggerEKR · Class 1Dental hand instrumentsLister
MANI Finger Pluggers
2011
Endodontic Pulp Canal FileEKS · Class 1Endodontic filesLister
MANI K Files
2011
Endodontic BroachEKW · Class 1Endodontic filesLister
ANTAEOS BARBED BROACHES
2006
Ultrasonic ScalerELC · Class 2Ultrasonic scalersLister
Acteon IrriSafe Tips
2010
Dental CementEMA · Class 2Dental cementsLister
AH PLUS SEALERKERR EWT SEALER
2006

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

Also lists devices cleared under other names

E/T Endodontic Technologies, Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Satelec (1), Dentsply Intl., Inc. (1), Pulpdent Corporation (1).

Decided510(k)DeviceApplicantDevice type
20 Apr 2005K050895SURPASSON P5 NEWTRONSatelecELC Ultrasonic Scaler
5 Jan 1998K974140ADHESIVE HYBRID IONOMER CEMENTDentsply Intl., Inc.EMA Dental Cement
30 Nov 1994K944945PULPDENT CALCIUM HYDROXIDE PREPARATIONSPulpdent CorporationEJK Calcium Hydroxide Cavity Liner

Registered establishments

EstablishmentLocationWhat it does
E/T ENDODONTIC TECHNOLOGIES, LTD.FDA reg. 3004569445HALIFAX Nova Scotia, CanadaForeign exporter, Repacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9063656). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.