Dental Device Guide
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Registered with FDA

Dentonics Inc

Monroe, NC, United States. Lists 12 dental device types with FDA across 1 registered establishment.

FDA owner/operator1721647Repacker / relabeler
Device types listed
12
Brands and models
16
510(k) clearances
0as applicant
Markets registered in
991 registrations outside the US
Establishments
1United States

Registered in 9 markets

Where regulators' registries name Dentonics Inc as the manufacturer or the registration holder of a device.

All markets
United States: 12 device types listedSaudi Arabia: 38 registrationsCosta Rica: 35 registrationsColombia: 8 registrationsAustralia: 6 registrationsIsrael: 1 registrationsSerbia: 1 registrationsSouth Korea: 1 registrationsTaiwan: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAListerDentonics Inc12 device types—Below
Saudi ArabiaSFDAManufacturerDENTONICS,INC38—Pure Global AI
Costa RicaMinisterio de SaludManufacturerDENTONICS.INC35—Pure Global AI
ColombiaINVIMAManufacturerDENTONICS, INC.DENTONICS INC.8—Pure Global AI
AustraliaTGAManufacturerDentonics Inc62013–2015Pure Global AI
IsraelAMARManufacturerDentonics INC.1—Pure Global AI
SerbiaALIMSManufacturerDentonics, Inc.12023–2023Pure Global AI
South KoreaMFDSManufacturerDentonics12008–2008Pure Global AI
TaiwanTFDAManufacturerDENTONICS, INC.12025–2025Pure 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 Dentonics Inc currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Resin Tooth Shade MaterialEBF · Class 2Dental compositesLister
Master-DentMaster-Dent Anterior/Posterior Composite RestorativeMaster-Dent Core Build-Up MaterialMaterial, Tooth Shade, Resin
2011
Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2—Lister
Master-Dent
2011
Pit and Fissure Sealant and ConditionerEBC · Class 2Sealants & varnishesLister
Master-DentMaterial, Tooth Shade, Resin
2011
Impression MaterialELW · Class 2Impression materialsLister
Master-Dent
2012
Dental CementEMA · Class 2Dental cementsLister
Master-Dent
2011
Oral Cavity Abrasive Polishing AgentEJR · Class 1Polishing & prophylaxisLister
Master-Dent
2011
Resin Filling Material CoatingEBD · Class 2—Lister
Master-Dent
2011
Resin Temporary Crown and BridgeEBG · Class 2Temporary crown & bridge materialsLister
Master-Dent
2011
Preformed Impression TrayEHY · Class 1Impression traysLister
Master-Dent
2001
Zinc Oxide EugenolEMB · Class 1Dental cementsLister
Master-Dent
2001
Root Canal Filling ResinKIF · Class 2Root canal filling materialsLister
Root Canal Sealer
2025
Cavity VarnishLBH · Class 2Sealants & varnishesLister
Master-Dent
2011

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

Dentonics Inc 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: Scientific Pharmaceuticals (18), Crown Delta Corp. (3), Prevest Denpro Limited (1), Dmp, Ltd. (1).

Decided510(k)DeviceApplicantDevice type
23 May 2022K212563CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/LiquidPrevest Denpro LimitedKIF Root Canal Filling Resin
28 Sep 2012K121915BRIGHT RESTORATIVE MATERIALSDmp, Ltd.EBF Resin Tooth Shade Material
4 Aug 2004K041886PROVISOScientific PharmaceuticalsEBG Resin Temporary Crown and Bridge
14 May 2004K041028CROWN DELTA HYDROPHILIC IMPRESSION MATERIALCrown Delta Corp.ELW Impression Material
21 Jul 2000K001446LIGHT-CURED ORTHODONTIC BAND CEMENTScientific PharmaceuticalsDYH Resin Bracket and Tooth Conditioner Adhesive
7 Jan 1994K930248VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEMCrown Delta Corp.ELW Impression Material
13 Dec 1993K934184FASTFILScientific PharmaceuticalsEMA Dental Cement
5 Oct 1990K903551TEMPOREXScientific PharmaceuticalsEBF Resin Tooth Shade Material
16 Apr 1990K895386GLASIONScientific PharmaceuticalsEMA Dental Cement
2 Dec 1988K884081INTERIM, TEMPORARY CEMENTScientific PharmaceuticalsEMA Dental Cement
12 Nov 1987K873686DIAMOND-LUSTER DENTAL POLISHING PASTEScientific PharmaceuticalsEJR Oral Cavity Abrasive Polishing Agent
11 Apr 1986K860633FLUOROSEAL, DENTIN SEALER AND CAVITY LINERScientific PharmaceuticalsLBH Cavity Varnish
7 Sep 1984K843098APCO FISSURE SEALER & BONDING AGENTScientific PharmaceuticalsEBC Pit and Fissure Sealant and Conditioner
17 Aug 1984K842403LUSTER, DENTAL POLISHING PASTEScientific PharmaceuticalsEJR Oral Cavity Abrasive Polishing Agent
21 Feb 1984K833810CURAY-MATCH PAINT-ON COMPOSITE RESTORScientific PharmaceuticalsEBF Resin Tooth Shade Material
19 Oct 1983K832781CURAY-SUPPORT, CORE BUILD-UP MATERIALScientific PharmaceuticalsEBF Resin Tooth Shade Material
18 Jul 1983K831495CURAY-ECLIPSE VISIBLE LIGHT CURED ORTHOScientific PharmaceuticalsDYH Resin Bracket and Tooth Conditioner Adhesive
28 Dec 1982K823510CURAY ANTERIOR/POSTERIOR RESTORATIVEScientific PharmaceuticalsEBF Resin Tooth Shade Material
8 Jul 1980K801380CROWN DELTA SILICONE IMPRESSION MATERIALCrown Delta Corp.ELW Impression Material
30 Nov 1979K792140COMPOSITE RESTORATIVE, PASTE/TYPEScientific PharmaceuticalsEBF Resin Tooth Shade Material
10 Aug 1979K791132SCI-PHARM ORTHODONTIC ADHESIVEScientific PharmaceuticalsDYH Resin Bracket and Tooth Conditioner Adhesive
10 Aug 1979K791078ANTERIOR/POSTERIOR RESTORATIVE, BONDScientific PharmaceuticalsEBD Resin Filling Material Coating
6 Jul 1979K790788FISSURE SEALER AND BONDING AGENTScientific PharmaceuticalsEBC Pit and Fissure Sealant and Conditioner

Registered establishments

EstablishmentLocationWhat it does
DENTONICS, INC.FDA reg. 1721647MONROE, NC, United StatesRepacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 1721647). 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.