Heliomat
FDA 510(k) K802684 · Vivadent (Usa), Inc.
510(k) numberK802684
Submission
- Device name
- Heliomat
- Applicant
- Vivadent (Usa), Inc.
Mchenry, IL, US - Received
- October 28, 1980
- Decision date
- November 24, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EAY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K953192 | Model A15-103EAY · Traditional | Beaverstate Dental, Inc. | 09/05/1995SE |
| K953191 | Model A15-101EAY · Traditional | Beaverstate Dental, Inc. | 09/05/1995SE |
| K935718 | Jedental VLC Dental Curing LightEAY · Traditional | Jedental Co., Inc. | 01/26/1994SE |
| K871816 | Strykerscope Tm/Orthoscope Tm/Stryker Miniscope TMEAY · Traditional | Stryker Corp. | 08/03/1987SE |
| K831976 | Power OpticEAY · Traditional | Ritter Co. | 08/12/1983SE |
| K831824 | Dental Electronic/S.B.R Trading Bu HandEAY · Traditional | Silverman'S | 08/11/1983SE |
| K820907 | DentiscopeEAY · Traditional | Chayes Virginia, Inc. | 05/05/1982SE |
| K812605 | Fiber Optic Light Source IEAY · Traditional | Venture Technology, Inc. | 10/02/1981SE |
| K802716 | Den-Mat Fiber Optic Halogen LightEAY · Traditional | Den-Mat Corp. | 11/12/1980SE |
| K801592 | Fiber Optic HoseEAY · Traditional | Lares Manufacturing Co., Inc. | 07/21/1980SE |
More from Lares Manufacturing Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K863831 | Vivadent FilpinEBL · Traditional | 10/14/1986SE |
| K823409 | Heliosit-OrthodonticDYH · Traditional | 01/21/1983SE |
| K813015 | HeliosealEBC · Traditional | 12/02/1981SE |
| K802679 | SilanitEBG · Traditional | 12/17/1980SE |
| K802683 | HeliositEBF · Traditional | 11/24/1980SE |
| K802682 | Contact SealEBC · Traditional | 11/24/1980SE |
| K802681 | HeliobondKLE · Traditional | 11/24/1980SE |
| K802685 | ReolitEJK · Traditional | 11/12/1980SE |
| K802680 | Isopast-DsEBF · Traditional | 11/12/1980SE |
| K801227 | SilicapEMA · Traditional | 08/12/1980SE |
Questions and answers
When was Heliomat cleared by the FDA?
Heliomat (K802684) received a 510(k) decision of Substantially Equivalent on November 24, 1980, 27 days after the submission was received.
What is the product code of K802684?
The FDA product code is EAY – Light, Fiber Optic, Dental, a Class I (low risk) device regulated under 21 CFR 872.4620.