Spaceline Three Way Syringe
FDA 510(k) K801686 · Pacific Dental Corp.
510(k) numberK801686
Submission
- Device name
- Spaceline Three Way Syringe
- Applicant
- Pacific Dental Corp.
Mchenry, IL, US - Received
- July 21, 1980
- Decision date
- August 4, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K931772 | Suretip Syringe Tip CoverECB · Traditional | Western M/D, Inc. | 03/07/1994SE |
| K931137 | Dental Syringe TipECB · Traditional | A-Dec, Inc. | 11/29/1993SE |
| K923876 | Riskontrol Single UseECB · Traditional | Riskontrol | 04/05/1993SE |
| K923285 | Pro-Tip Disposable 3/1 Syringe NozzleECB · Traditional | Smith & Nephew, Inc. | 09/15/1992SE |
| K920499 | Sani-TipECB · Traditional | Dw Industries, Inc. | 05/03/1992SE |
| K911756 | Posterior Nasal Epistaxis InstrumentsECB · Traditional | Richard Wolf Medical Instruments Corp. | 10/24/1991SE |
| K890290 | Brace (Orafix Special)ECB · Traditional | Norcliff Thayer, Inc. | 03/29/1989SE |
| K863024 | Seringa Triplice S.L.ECB · Traditional | Sds Dental, Inc. | 09/25/1986SE |
| K854699 | Tubing SyringECB · Traditional | Almore Intl., Inc. | 01/06/1986SE |
More from Almore Intl., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K821782 | Beach Anesthetic Syringe Cartr. TypeEJI · Traditional | 07/20/1982SE |
| K821790 | Beach Excavator's No. 1 & No. 2EKD · Traditional | 07/06/1982SE |
| K821789 | Beach Curette No. 2 and No. 3 T.G.EMS · Traditional | 07/06/1982SE |
| K821788 | Beach Deriosteal Elevator, #2 StraightEMJ · Traditional | 07/06/1982SE |
| K821787 | Beach Surgical Pliers Non-HookEJY · Traditional | 07/06/1982SE |
| K821786 | Beach ScalersEMN · Traditional | 07/06/1982SE |
| K821785 | Beach Amalgam CarverEKH · Traditional | 07/06/1982SE |
| K821784 | Beach Gingival Retraction Instr. Type BEIG · Traditional | 07/06/1982SE |
| K821783 | Beach Silicate Filling & Lining Applic. · Traditional | 07/06/1982SE |
| K821780 | Beach Explorer No. 23T.G.EKB · Traditional | 07/06/1982SE |
Questions and answers
When was Spaceline Three Way Syringe cleared by the FDA?
Spaceline Three Way Syringe (K801686) received a 510(k) decision of Substantially Equivalent on August 4, 1980, 14 days after the submission was received.
What is the product code of K801686?
The FDA product code is ECB – Unit, Syringe, Air And/Or Water, a Class I (low risk) device regulated under 21 CFR 872.4565.