Identifiers
- 510(k) Number
- K211101 FDA 510(k)
- FDA Product Code
- EBG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3770 FDA 510(k)
- Regulation Number
- 872.3770 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
E-Temp is a dental device used in clinical applications. It is classified under the dental advisory committee for use in dental procedures.
This device is authorized via FDA 510(k) clearance under K211101. It is manufactured by Envisiontec GmbH, located in Gladbeck, Germany.
Frequently asked questions
What is the E-Temp device used for?
E-Temp is a dental device intended for use in clinical dental procedures. It is categorized under the dental advisory committee for professional clinical applications.
What is the regulatory status of E-Temp?
E-Temp has received FDA 510(k) clearance under the submission number K211101. This indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.
Who is the manufacturer of the E-Temp device?
The device is manufactured by Envisiontec GmbH, which is located in Gladbeck, Germany. The company is the official applicant for the FDA 510(k) clearance associated with this product.
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. Sources consulted: K211101 - E-Temp - Dental, PDF 7ULVOHU Ju - Food and Drug Administration, Envisiontec GmbH FDA 510 (k) Products 2022, Envision Tec | Dentalstoff Onlineshop - Der Onlineshop für Labor & Praxis
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211101 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Envisiontec GmbH
Sources (1)
- FDA 510(k) K211101 24 fields · synced Sep 22, 2026