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Sign in to claim this brandDMP DENTAL INDUSTRY S.A.
US
Last updated May 27, 2026
What DMP DENTAL INDUSTRY S.A. makes
DMP Dental Industry S.A. manufactures dental composite resins, including flowable and posterior variants, as well as silicone-based impression materials for dental molds. Their portfolio also includes temporary crowns and bridges, dental etching gels for surface preparation, and bonding agents for dentine adhesion, designed for restorative procedures.
All listed devices fall under FDA Class II regulation and are authorised via the 510(k) pathway or the FDA’s Unique Device Identification (UDI) system. The company’s products are registered under these U.S. regulatory frameworks, ensuring compliance with dental material standards. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of dental devices does DMP Dental Industry S.A. manufacture?
DMP Dental Industry S.A. specializes in dental restorative materials, primarily producing dental composite resins (including flowable and posterior variants), silicone-based dental impression materials, temporary crowns and bridges, dental etching gels, and dentine bonding agents. These products are designed for use in dental restorations and procedures, focusing on materials that require precise regulatory oversight due to their direct contact with oral tissues.
Where is DMP Dental Industry S.A. based, and how does that affect its regulatory compliance?
DMP Dental Industry S.A. is based in the United States, which means its devices are subject to FDA regulations. Since all its listed devices fall under FDA Class II classification, they must comply with the agency’s requirements for dental materials, including pre-market submissions via the 510(k) pathway or registration under the FDA’s Unique Device Identification (UDI) system. The U.S. regulatory framework ensures these products meet safety and effectiveness standards for dental use.
Which regulatory registries or databases list DMP Dental Industry S.A.’s devices?
DMP Dental Industry S.A.’s devices are registered under the FDA’s 510(k) clearance process and the FDA’s Unique Device Identification (UDI) system. These registries ensure traceability and compliance tracking for Class II dental devices, which require additional scrutiny due to their role in patient care. The UDI system, in particular, helps streamline post-market surveillance and recall management for authorised products.
How are DMP Dental Industry S.A.’s dental devices classified under FDA regulations?
All of DMP Dental Industry S.A.’s listed dental devices are classified as FDA Class II. This classification applies to products that pose moderate risk and require special controls beyond general controls to ensure their safety and effectiveness. For dental materials like composites, impression materials, and bonding agents, Class II status means they must undergo pre-market submissions (such as 510(k) clearances) or UDI registration to demonstrate compliance with performance standards and manufacturing practices.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- dmpdental.com
- —
- —
- [email protected]
- Phone
- +302299023041
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 728534814
Catalogue (174)
Page 1 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Single Bonding | 5ml | EUDAMEDFDA UDI | Class II | Active |
| Bright Light | C1, 0.25g x 20 | EUDAMEDFDA UDI | Class II | Active |
| Bright Light | A4, 0.25g x 20 | EUDAMEDFDA UDI | Class II | Active |
| Bright Posterior | A1, 0.25g x 20 | EUDAMEDFDA UDI | Class II | Active |
| Bright Temporary C&B | B1, 7.5g (1:1) | EUDAMEDFDA UDI | Class II | Active |
| Etching Gel | 50ml | EUDAMEDFDA UDI | Class II | Active |
| BONASIL A+ Putty | 380ml | EUDAMEDFDA UDI | Class II | Active |
| Bonascan Putty | 380ml | FDA UDI | Class II | Active |
| Bright Light | Incisal, 4.5g | EUDAMEDFDA UDI | Class II | Active |
| Bright Light | Bleach Extra, 4.5g | EUDAMEDFDA UDI | Class II | Active |
| Bright Light | C3, 0.25g x 20 | EUDAMEDFDA UDI | Class II | Active |
| Bright Light Flow | A2 Opaque, 2g | EUDAMEDFDA UDI | Class II | Active |
| Nanoceram-Bright | A3, 0.25g x 20 | EUDAMEDFDA UDI | Class II | Active |
| Bright Light Flow | A3, 2g | EUDAMEDFDA UDI | Class II | Active |
| Bright Temporary C&B | Bleach, 7.5g (1:1) | EUDAMEDFDA UDI | Class II | Active |
| Nanoceram-Bright | B3, 4g | EUDAMEDFDA UDI | Class II | Active |
| BONASIL A+ Heavy | 380ml | FDA UDI | Class II | Active |
| BONASIL A+ Mono | 380ml | EUDAMEDFDA UDI | Class II | Active |
| Nanoceram-Bright | Bleach Extra, 0.25g x 20 | EUDAMEDFDA UDI | Class II | Active |
| Bright Temporary C&B | A1, 50ml (10:1) | EUDAMEDFDA UDI | Class II | Active |
| Bright Temporary C&B | A3, 7.5g (1:1) | EUDAMEDFDA UDI | Class II | Active |
| BONA-BITE Air | Fast Set, 50ml | FDA UDI | Class II | Active |
| Bonascan Mono | Fast Set, 50ml | FDA UDI | Class II | Active |
| BONA-BITE Air Chocomint | 50ml | FDA UDI | Class II | Active |
| Bright Posterior | A2, 4g | EUDAMEDFDA UDI | Class II | Active |
| Bright Light | A1, 4.5g | FDA UDI | Class II | Active |
| Nanoceram-Bright | B4, 0.25g x 20 | EUDAMEDFDA UDI | Class II | Active |
| Nanoceram-Bright Flow | A1, 2g | FDA UDI | Class II | Active |
| Nanoceram-Bright Flow | Bleach Extra, 2g | FDA UDI | Class II | Active |
| BONASIL A+ Light Extra | Regular Set, 50ml | FDA UDI | Class II | Active |
| Bright Temporary C&B | B1, 50ml (10:1) | FDA UDI | Class II | Active |
| Nanoceram-Bright | A3, 4g | EUDAMEDFDA UDI | Class II | Active |
| Bright Light | Bleach, 0.25g x 20 | EUDAMEDFDA UDI | Class II | Active |
| Bonascan Bite Air | Regular Set, 50ml | FDA UDI | Class II | Active |
| Bright Light | Incisal, 0.25g x 20 | EUDAMEDFDA UDI | Class II | Active |
| Nanoceram-Bright | C4, 0.25g x 20 | EUDAMEDFDA UDI | Class II | Active |
| Etching Gel | 3ml | EUDAMEDFDA UDI | Class II | Active |
| Nanoceram-Bright | A3.5, 4g | EUDAMEDFDA UDI | Class II | Active |
| Nanoceram-Bright Flow | A3.5, 2g | EUDAMEDFDA UDI | Class II | Active |
| Nanoceram-Bright | C4, 4g | EUDAMEDFDA UDI | Class II | Active |
| BONASIL A+ Light HTS | 50ml | FDA UDI | Class II | Active |
| BONASIL A+ Light | Regular Set, 50ml | FDA UDI | Class II | Active |
| Nanoceram-Bright Flow | B2, 2g | FDA UDI | Class II | Active |
| BONASIL A+ Alginate Free | 380ml | EUDAMEDFDA UDI | Class II | Active |
| Bright Light | C4, 0.25g x 20 | EUDAMEDFDA UDI | Class II | Active |
| Bonascan Light | Regular Set, 50ml | FDA UDI | Class II | Active |
| Nanoceram-Bright | A2, 4g | EUDAMEDFDA UDI | Class II | Active |
| Nanoceram-Bright | B4, 4g | EUDAMEDFDA UDI | Class II | Active |
| Nanoceram-Bright | D4, 0.25g x 20 | EUDAMEDFDA UDI | Class II | Active |
| Bright Temporary C&B | B1, 50ml (4:1) | EUDAMEDFDA UDI | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- DMP Dental Industry S.A. Markopoulo Attiki · GR FEI 3008966075