FineEtch (FineEtch-10 1.2ml +3 more)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- FineEtch-10 5ml EUDAMEDFineEtch-37 1.2ml 20ea pack EUDAMEDFineEtch-10 1.2ml EUDAMED
- Device Name
- FineEtch EUDAMED
- Model / Reference
- #360110P03 EUDAMED#3601P20 EUDAMED#360110P04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809262954401 EUDAMED08809262954029 EUDAMED08809262954043 EUDAMED
- Basic UDI-DI
- B-08809262954401 EUDAMEDB-08809262954029 EUDAMEDB-08809262954043 EUDAMED
- 510(k) Number
- K242675 FDA 510(k)
- FDA Product Code
- KLE FDA 510(k)
- EMDN Code
- Q01010402 ENAMEL-DENTINAL ETCHING MATERIALS EUDAMED
- Models / Variants
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3200 FDA 510(k)
- Regulation Number
- 872.3200 FDA 510(k)
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
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
The FineEtch series is a resin-based agent for tooth bonding, classified as a dental adhesive system. These single-use, liquid formulations are designed to enhance adhesion between dental restorative materials and tooth structure, ensuring durable bonding for restorative procedures.
Supplied as sterile, single-use cartridges in varying volumes (1.2ml and 5ml) and concentrations (10% and 37%), the FineEtch agents are intended for use in dental clinics. They comply with FDA 510(k) and MDD regulations, with MRI safety not specified. Proper storage requires protection from light and extreme temperatures, and the 20ea pack is available for bulk use. Authorized under KLE product code and regulation number 872.3200.
Frequently asked questions
What are the key differences between the FineEtch-10 and FineEtch-37 concentrations, and how might this affect my choice for a procedure?
The FineEtch series comes in two concentrations: 10% and 37%. The primary difference lies in their intended application strength. The 10% concentration is generally used for standard bonding procedures where a milder etch is sufficient, while the 37% concentration provides a stronger etch for more demanding restorative cases, such as deep cavities or high-stress areas. The choice depends on the specific bonding requirements of the tooth structure and restorative material being used.
Are the FineEtch cartridges reusable, and if not, how should they be handled to ensure sterility and prevent contamination?
The FineEtch cartridges are single-use only, as explicitly stated in the product description. To maintain sterility, they should remain unopened until use and be handled with sterile gloves. Once opened, the cartridge should be discarded immediately after use to avoid contamination. The sterile packaging ensures safety for clinical procedures, but reuse is not recommended or supported.
What storage conditions are required for FineEtch cartridges, and why is this important?
FineEtch cartridges must be stored protected from light and extreme temperatures to preserve their efficacy. Light exposure can degrade the resin-based formulation, while temperature fluctuations may compromise the adhesive properties. Proper storage ensures the product remains effective for bonding procedures and maintains its regulatory compliance.
How are the FineEtch cartridges packaged, and what options are available for bulk purchasing?
FineEtch cartridges are supplied individually in sterile, single-use packaging, with volumes of 1.2ml or 5ml. For bulk purchasing, a 20-pack of 1.2ml FineEtch-37% cartridges is available, which is ideal for clinics performing frequent restorative procedures. This packaging option helps streamline inventory while maintaining sterility.
What regulatory pathways does FineEtch follow, and how does this impact its use in clinical settings?
FineEtch is authorized under FDA 510(k) clearance and MDD (Medical Device Directive) compliance, indicating it meets U.S. and European regulatory standards for dental adhesives. This ensures its safety and effectiveness for bonding applications in clinical settings. The KLE product code and regulation number 872.3200 further categorize it as a dental adhesive system, confirming its intended use for enhancing adhesion between restorative materials and tooth structure.
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 | K242675 | Class II | Active |
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Manufacturer
- Manufacturer
- Spident Co., Ltd.
Sources (4)
- FDA 510(k) K242675 24 fields · synced Sep 18, 2026
- EUDAMED 5ea427fc-7cef-47fe-a816-acb7ad952368 61 fields · synced Jul 15, 2026
- EUDAMED fc24409f-1cd3-466b-8c60-600f89397be7 61 fields · synced Jul 20, 2026
- EUDAMED 1dd7ffef-af34-4cb4-8455-271b313d3608 61 fields · synced Jul 21, 2026