Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008966075

FEI Number

3008966075

Entity Name

DMP Dental Industry S.A.

City/State/Country

Markopoulo Attiki, GR

Establishment Address

Kalyvion Avenue, Markopoulo Industrial Zone, Markopoulo Attiki 19003, GR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

DMP Dental Industry S.A. (Owner Number: 10037473)

Owner / Operator Contact Address

Kalyvion Avenue, Markopoulo Industrial Zone, Markopoulo, GR-I 19003, GR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K192830

PMA Number

N/A

All Registered Proprietary Names

PIT & FISSURE SEALANT ETCHING GEL NANOCERAM-BRIGHT FLOW BRIGHT LIGHT BRIGHT LIGHT FLOW BRIGHT FLOW CORE BRIGHT POSTERIOR SINGLE BONDING TRAY ADHESIVE DMP MIXER T-1:1 3.2-12-S LIGHT BLUE (50) DMP MIXER T-1:1 4.2-12-D YELLOW (50) DMP MIXER T-1:1 2.5-10-D BROWN (50) DMP MIXER T-1:1 2.5-10-SW BLUE (50) DMP MIXER T-1:1 6.5-12-D TEAL (50) DMP MIXER T-4/10:1 3.2-16-S LIGHT BLUE/ORANGE (50) DMP MIXER DYNAMIC-5:1 380ml YELLOW (50) DMP MIXER T-1:1 5.4-12-D PINK (50) Bright Cavity Liner BRIGHT TEMPORARY C&B

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2011-07-18
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-07-18
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2012-11-22
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2012-11-22
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2011-07-18
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2022-11-09
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2020-05-27
EJK	Liner, Cavity, Calcium Hydroxide	Dental	Class 2	872.3250	2026-04-30
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2020-09-08

Official Correspondent

Dimitris Prantsidis

US Agent Details

Allison Orsley Business: DMP USA LLC Email: aorsley@dmpdental.us Phone: (908) 5533196

Related Public Records

Same Entity

DMP Dental Industry S.A.

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
K020499	Jeneric/Pentron, Inc.	BOND-3 ADHESIVE	2002-04-22

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.).
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008966075. Last updated year: 2026. Please use registration number 3008966075 when referencing this establishment in official correspondence.