Opus I Option - Fiber Optic L System
FDA 510(k) K761331 · Syntex Corp.
510(k) numberK761331
Submission
- Device name
- Opus I Option - Fiber Optic L System
- Applicant
- Syntex Corp.
Mchenry, IL, US - Received
- December 27, 1976
- Decision date
- January 3, 1977
- 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 |
| K802684 | HeliomatEAY · Traditional | Vivadent (Usa), Inc. | 11/24/1980SE |
| K802716 | Den-Mat Fiber Optic Halogen LightEAY · Traditional | Den-Mat Corp. | 11/12/1980SE |
More from Den-Mat Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K920314 | Txit D.A.U. Barbiturate Assay (Modification)DIS · Traditional | 04/17/1992SE |
| K843593 | Surgipress Surgical LoopHRQ · Traditional | 10/24/1984SE |
| K780997 | Amalgam AlloyEJJ · Traditional | 07/27/1978SE |
| K780769 | S-100 CT ScannerJAK · Traditional | 06/02/1978SE |
| K780483 | Fiber Optic HandpieceEFB · Traditional | 04/28/1978SE |
| K761332 | Hi-Sensitivity Mode Option for S60-1AJAK · Traditional | 12/30/1976SE |
| K761330 | Syntex System 6000JAK · Traditional | 12/30/1976SE |
| K761264 | Options for Star Dental Opus IDYN · Traditional | 12/23/1976SE |
| K761033 | Computerized Tomography ScannerJAK · Traditional | 11/24/1976SE |
Questions and answers
When was Opus I Option - Fiber Optic L System cleared by the FDA?
Opus I Option - Fiber Optic L System (K761331) received a 510(k) decision of Substantially Equivalent on January 3, 1977, 7 days after the submission was received.
What is the product code of K761331?
The FDA product code is EAY – Light, Fiber Optic, Dental, a Class I (low risk) device regulated under 21 CFR 872.4620.