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Sign in to claim this brandDental Technologies, Inc.
United States·US-MF-000027130
Last updated September 17, 2026
About
Dental Technologies is celebrating 27 years in business! In 1999, we started out as a small dental medical device manufacturer focusing on restorative and orthodontic materials. Through the hard work of our dedicated employees and the support of our valued customers, we have grown the scope of our business over the past 27 years. In addition to our medical devices, we now manufacture a wide range of oral health products including toothpastes, oral rinses, gels, and pastes. We are proud of our team’s technical knowledge and ability to solve problems for our customers.
From the manufacturer's own website. Source
What Dental Technologies, Inc. makes
Dental Technologies, Inc. manufactures dental materials for restorative and orthodontic procedures, including light-cure and self-cure composite resins, alginate impression materials, dental etching solutions, bonding agents, orthodontic bracket adhesives, pit/fissure sealants, and zinc phosphate and glass ionomer cements.
The company’s products are classified as Class II and Class IIa devices, with listings in the EU’s eudamed registry and the FDA’s UDI system. The manufacturer is based in 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 Dental Technologies, Inc. manufacture?
Dental Technologies, Inc. specializes in dental materials used primarily for restorative and orthodontic treatments. Their portfolio includes dental composite resins (both light-cure and self-cure), alginate impression materials for creating dental molds, dental etching solutions to prepare tooth surfaces, bonding agents for dentine, orthodontic bracket adhesives, pit/fissure sealants to protect teeth, and dental cements like zinc phosphate and glass ionomer. These products are designed to support procedures like fillings, crowns, braces, and preventive care.
Where is Dental Technologies, Inc. based, and how does that affect its regulatory compliance?
Dental Technologies, Inc. is based in the United States. Since the company’s devices are listed in both the EU’s eudamed registry and the FDA’s UDI system, it operates under U.S. and EU regulatory frameworks. The U.S. classification system (e.g., Class II/IIa) aligns with FDA requirements, while EU listings ensure compliance with MDR/AMDR directives. The dual listing reflects the company’s global market presence, requiring adherence to both regional regulatory standards for device authorization.
Which regulatory registries list Dental Technologies, Inc.’s devices, and why does this matter?
Dental Technologies, Inc.’s devices are listed in eudamed (the EU’s medical device registry) and the FDA’s UDI system (Unique Device Identifier database). This matters because eudamed ensures traceability and compliance with EU Medical Device Regulations (MDR/AIMDR), while the FDA’s UDI system supports post-market surveillance, recalls, and device tracking in the U.S. market. Listing in both systems demonstrates the company’s ability to meet international regulatory requirements for its Class II/IIa devices.
How are Dental Technologies, Inc.’s devices classified, and what does that classification indicate?
Dental Technologies, Inc.’s devices are classified as Class II or Class IIa under regulatory frameworks. Class II devices generally pose moderate risks and require special controls beyond general controls (e.g., performance standards, labeling requirements). Class IIa is a subset of Class II with slightly lower risk profiles but still necessitates validation of safety and effectiveness. The classification determines the regulatory pathway for authorization, including testing, documentation, and post-market monitoring requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 6901, N Hamlin Ave, Lincolnwood, United States
- Website
- www.dentaltech.com
- facebook.com/DentalTechInc
- [email protected]
- Phone
- 18476775500
- PRRC Contact
- John Pontikis
- EUDAMED SRN
- US-MF-000027130
- FDA FEI Number
- 1413475
- DUNS Number
- —
Catalogue (370)
Page 1 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ALPHA-DENT® Porcelain Conditioner | 542.0101.001 | FDA UDI | Class II | Active |
| Alpha-Dent® Light Cure Hybrid Composite | 101.0801.001 | FDA UDI | Class II | Active |
| ALPHA-DENT® Light Cure Bracket Adhesive | 303.0202.001 | FDA UDI | Class II | Active |
| ALPHA-DENT® Glass Ionomer Cement | 307.0000.001 | FDA UDI | Class II | Active |
| Alpha-Dent® Light Cure Hybrid Composite | 101.0603.001 | FDA UDI | Class II | Active |
| Alpha Ii® Ap | 102.1401.002 | FDA UDI | Class II | Active |
| ALPHA-DENT® Self Cure Composite | 110.0010.001 | FDA UDI | Class II | Active |
| Alpha-Etch® 37 | 501.0103.002 | FDA UDI | Class II | Active |
| Alpha Ii® Ap | 102.0901.002 | FDA UDI | Class II | Active |
| Alpha Ii® Ap | 102.1001.002 | FDA UDI | Class II | Active |
| Alpha-Dent® Light Cure Hybrid Composite | 101.0703.001 | FDA UDI | Class II | Active |
| Alpha-Dent® Alginate Flavorings | 620.0502.001 | FDA UDI | Class II | Active |
| Alpha-Dent® Light Cure Hybrid Composite | 101.0103.001 | FDA UDI | Class II | Active |
| Alpha-Dent® Alginate Flavorings | 620.1002.001 | FDA UDI | Class II | Active |
| Alpha-Dent® Light Cure Hybrid Composite | 101.0010.001 | FDA UDI | Class II | Active |
| Alpha-Dent® Alginate Flavorings | 620.1202.001 | FDA UDI | Class II | Active |
| ALPHA-DENT® One Step Primer | 209.0101.001 | FDA UDI | Class II | Active |
| Alpha-Core® DC | 122.0003.002 | FDA UDI | Class II | Active |
| Alpha-Dent® Light Cure Hybrid Composite | 101.0403.001 | FDA UDI | Class II | Active |
| Alpha-Dent® Light Cure Hybrid Composite | 101.0503.001 | FDA UDI | Class II | Active |
| Alpha-Dent® Alginate Flavorings | 620.1402.001 | FDA UDI | Class II | Active |
| Alpha-Dent® Alginate Flavorings | 620.0802.001 | FDA UDI | Class II | Active |
| Alpha-Dent® Alginate Impression Material | 604.0503.001 | FDA UDI | Class II | Active |
| Alpha Ii® Ap | 102.0302.002 | FDA UDI | Class II | Active |
| Alpha Ii® Ap | 102.1501.002 | FDA UDI | Class II | Active |
| Alpha-Dent® Light Cure Hybrid Composite | 101.0601.001 | FDA UDI | Class II | Active |
| Alpha-Etch® 37 | 501.1204.002 | FDA UDI | Class II | Active |
| ALPHA-DENT® Self Cure Bonding Adhesive | 200.0202.001 | FDA UDI | Class II | Active |
| Alpha-Dent® Light Cure Hybrid Composite | 101.1903.001 | FDA UDI | Class II | Active |
| Alpha-Dent® Light Cure Hybrid Composite | 101.1701.001 | FDA UDI | Class II | Active |
| Alpha-Dent® Light Cure Hybrid Composite | 101.1101.001 | FDA UDI | Class II | Active |
| Alpha-Dent® Light Cure Hybrid Composite | 101.0000.001 | FDA UDI | Class II | Active |
| ALPHA-DENT® Light Cure Bonding Adhesive | 206.0102.001 | FDA UDI | Class II | Active |
| Alpha-Dent® Light Cure Hybrid Composite | 101.1503.001 | FDA UDI | Class II | Active |
| Alpha-Pro® White Varnish | 407.0701.002 | FDA UDI | Class II | Active |
| ALPHA-DENT® Zinc Phosphate Cement | 305.0000.001 | FDA UDI | Class II | Active |
| Alpha-Cal® | 414.0000.002 | FDA UDI | Class II | Active |
| ALPHA-DENT® Light Cure Bonding Adhesive | 206.0101.001 | FDA UDI | Class II | Active |
| Alpha Ii® Ap | 102.1602.002 | FDA UDI | Class II | Active |
| Alpha-Dent® Light Cure Hybrid Composite | 101.0803.001 | FDA UDI | Class II | Active |
| Alpha-Dent® Alginate Flavorings | 620.2602.001 | FDA UDI | Class II | Active |
| ALPHA-DENT® Light Cure Bonding Adhesive | 206.0000.001 | FDA UDI | Class II | Active |
| ALPHA-DENT® Zinc Phosphate Cement | 305.0201.001 | FDA UDI | Class II | Active |
| Alpha-Dent® Light Cure Hybrid Composite | 101.1203.001 | FDA UDI | Class II | Active |
| ALPHA-DENT® Light Cure Bracket Adhesive | 303.0204.001 | FDA UDI | Class II | Active |
| Alpha-Dent® Alginate Flavorings | 620.0902.001 | FDA UDI | Class II | Active |
| ALPHA-DENT® Self Cure Composite | 110.0020.001 | FDA UDI | Class II | Active |
| Alpha Ii® Ap | 102.0102.002 | FDA UDI | Class II | Active |
| ALPHA-DENT® Self Cure Bonding Adhesive | 200.0001.001 | FDA UDI | Class II | Active |
| ALPHA-DENT® One Step Bracket Adhesive | 301.0102.001 | FDA UDI | Class II | Active |
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