DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Packag…
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- DIAETCH EUDAMEDFDA UDI
- Generic Name
- Dental etching solution FDA UDI
- Device Name
- DiaEtch EUDAMEDBlue colored gel-type substance containing 37% phosphoric acid that corrodes enamel and dentine. FDA UDI
- Model / Reference
- DiaEtch Regular Package EUDAMEDA2001-3103 EUDAMEDDiaEtch Intro Kit EUDAMEDA2001-6940 EUDAMEDDiaEtch Refill Package Type A EUDAMEDA2001-3202 EUDAMEDRegular Package FDA UDIRefill Package Type A FDA UDI
- Description
- Blue colored gel-type substance containing 37% phosphoric acid that corrodes enamel and dentine. FDA UDI
Identifiers
- Catalog Number
- A2001-3103 FDA UDIA2001-3202 FDA UDI
- Primary DI / UDI-DI
- 08806383565172 EUDAMEDFDA UDI08806383565196 EUDAMEDFDA UDI08806383565738 EUDAMED
- Basic UDI-DI
- B-08806383565172 EUDAMEDB-08806383565738 EUDAMEDB-08806383565196 EUDAMED
- 510(k) Number
- K192273 FDA 510(k)
- FDA Product Code
- KLE FDA 510(k)FDA UDI
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
- GMDN Term
- Dental etching solution FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 872.3200 FDA 510(k)
- Regulation Number
- 872.3200 FDA 510(k)FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
The Diaetch series comprises resin-based dental bonding agents designed for tooth restoration. These devices adhere to enamel and dentin, providing a durable bond for composite restorations, inlays, or onlays in restorative dentistry. Their formulation supports mechanical retention and chemical bonding to ensure long-term stability of dental repairs.
Supplied as single-use packages, these kits are intended for use in clinical dental settings and are classified as Class II devices under FDA regulations. Each package contains sterile components for immediate application, with no requirement for reprocessing. The kits comply with FDA 510(k) clearance and the EU Medical Device Directive (MDD), ensuring adherence to stringent safety and performance standards for dental adhesives.
Frequently asked questions
Are the Diaetch bonding agents designed for use on specific types of dental restorations, and if so, which ones?
The Diaetch series is specifically formulated for tooth restoration, providing a durable bond for composite restorations, inlays, and onlays. Its resin-based adhesive adheres to both enamel and dentin, ensuring mechanical retention and chemical bonding for long-term stability in restorative dentistry.
How are the Diaetch packages supplied, and do they require any special handling before use?
The Diaetch kits are supplied as single-use, sterile packages designed for immediate clinical application. No reprocessing is required, and the sterile components are ready for use right out of the package, simplifying workflow in dental settings.
Are the Diaetch bonding agents reusable, or are they intended for single-use only?
The Diaetch bonding agents are explicitly designed as single-use packages. Each package contains sterile components intended for one application, eliminating the need for reprocessing or reuse.
What regulatory pathways have the Diaetch bonding agents followed, and what does that mean for their use in clinical settings?
The Diaetch series has obtained FDA 510(k) clearance and complies with the EU Medical Device Directive (MDD), confirming it meets stringent safety and performance standards for dental adhesives. This classification as a Class II device under FDA regulations ensures it adheres to rigorous quality and efficacy requirements for use in clinical dentistry.
What types of Diaetch packages are available, and how do they differ from one another?
The Diaetch series includes four package types: the Economic Package Type A, Regular Package, Refill Package Type A, and Intro Kit. While the exact differences in contents or quantities aren’t specified, these variations likely cater to different clinical needs—such as bulk purchasing (Refill), introductory use (Intro Kit), or cost-effective options (Economic). All are single-use and sterile, ensuring consistency across applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K192273 | Class II | Active |
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Manufacturer
- Manufacturer
- Diadent Group International
Sources (6)
- FDA 510(k) K192273 24 fields · synced Sep 18, 2026
- FDA UDI 1f60acdd-40d3-48aa-9d9c-cd38ecf7b57c 35 fields · synced May 30, 2026
- FDA UDI 39bfe061-52e7-4888-833c-31504f8d2cc7 35 fields · synced May 30, 2026
- EUDAMED b3168134-f348-4117-b578-6031df4c1b7d 61 fields · synced Jul 9, 2026
- EUDAMED 2b75ba77-3b04-42d9-8b83-050eab957704 61 fields · synced Jul 31, 2026
- EUDAMED c417c0a5-da44-416a-8e37-f6fecb9f805f 61 fields · synced Aug 4, 2026