Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1721647

FEI Number

1721647

Entity Name

DENTONICS, INC.

City/State/Country

MONROE, NC, US

Establishment Address

2833 TOPHILL RD., MONROE, NC 28110, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

DENTONICS, INC. (Owner Number: 1721647)

Owner / Operator Contact Address

2833 TOPHILL RD., --, Monroe, NC 28110, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K833810

PMA Number

N/A

All Registered Proprietary Names

Material, Tooth Shade, Resin Master-Dent Master-Dent Master-Dent Master-Dent Master-Dent Master-Dent Master-Dent Root Canal Sealer Master-Dent Master-Dent Core Build-Up Material Master-Dent Master-Dent Master-Dent Master-Dent Master-Dent Master-Dent Master-Dent Master-Dent Master-Dent

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2021-12-17
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2021-12-17
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2011-12-28
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2011-12-28
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-12-28
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2011-12-28
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2001-11-16
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2011-12-28
ELW	Material, Impression	Dental	Class 2	872.3660	2012-02-20
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2025-07-25
ELW	Material, Impression	Dental	Class 2	872.3660	2012-02-20
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2012-11-06
EBD	Coating, Filling Material, Resin	Dental	Class 2	872.3310	2011-12-28
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2011-12-28
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2011-12-28
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2011-12-28
EMA	Cement, Dental	Dental	Class 2	872.3275	2011-12-28
EMA	Cement, Dental	Dental	Class 2	872.3275	2011-12-28
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2011-12-28
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2011-12-28
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-12-28

Official Correspondent

RANDY LEANDER

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DENTONICS, 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
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23
K161684	Reliance Orthodontic Products, Inc.	Quantum LB	2016-10-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

Similar Registrations

Registration Number	Establishment Name	Location
3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
3006694515	indigodental GmbH	Pinneberg Schleswig-Holstein, DE
3012421607	MAINLINE MEDICAL DENTAL SUPPLY	North York Ontario, CA
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
9612352	IVOCLAR VIVADENT AG	SCHAAN, LI

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1721647. Last updated year: 2026. Please use registration number 1721647 when referencing this establishment in official correspondence.