Dental Electronic/S.B.R Trading Bu Hand
FDA 510(k) K831824 · Silverman'S
510(k) numberK831824
Submission
- Device name
- Dental Electronic/S.B.R Trading Bu Hand
- Applicant
- Silverman'S
Mchenry, IL, US - Received
- June 7, 1983
- Decision date
- August 11, 1983
- 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 |
| K820907 | DentiscopeEAY · Traditional | Chayes Virginia, Inc. | 05/05/1982SE |
| K812605 | Fiber Optic Light Source IEAY · Traditional | Venture Technology, Inc. | 10/02/1981SE |
| K802684 | HeliomatEAY · Traditional | Vivadent (Usa), Inc. | 11/24/1980SE |
| 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 |
|---|---|---|
| K801975 | Little Giant I & II Handpiece ControlEIA · Traditional | 09/09/1980SE |
Questions and answers
When was Dental Electronic/S.B.R Trading Bu Hand cleared by the FDA?
Dental Electronic/S.B.R Trading Bu Hand (K831824) received a 510(k) decision of Substantially Equivalent on August 11, 1983, 65 days after the submission was received.
What is the product code of K831824?
The FDA product code is EAY – Light, Fiber Optic, Dental, a Class I (low risk) device regulated under 21 CFR 872.4620.