Tubing Syring
FDA 510(k) K854699 · Almore Intl., Inc.
510(k) numberK854699
Submission
- Device name
- Tubing Syring
- Applicant
- Almore Intl., Inc.
Portland, OR, US - Received
- November 21, 1985
- Decision date
- January 6, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code ECB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K942519 | Uni-Syringe, Uni-Tip and Access Syringe TipsECB · Traditional | Bull Frog Mfg. Co. | 08/23/1994SE |
| 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 |
| K801686 | Spaceline Three Way SyringeECB · Traditional | Pacific Dental Corp. | 08/04/1980SE |
More from Pacific Dental Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K862851 | Almore Face Mask · Traditional | 08/12/1986SE |
| K854692 | Monarch II Bleaching InstrumentEEG · Traditional | 05/12/1986SE |
| K854696 | Op II Visible Light Curing SystemEBZ · Traditional | 03/26/1986SE |
| K854691 | Diamond Burs-HandpieceEJL · Traditional | 03/25/1986SE |
| K854690 | Diamonds Burs-Composit FinishingEJL · Traditional | 03/25/1986SE |
| K854700 | Ez-On Tubing Conditioner (Lubricant) · Traditional | 03/12/1986SE |
| K854702 | Plastic Mounting RingsEJP · Traditional | 03/06/1986SE |
| K854701 | Retract-A-CordJES · Traditional | 03/06/1986SE |
| K854697 | Tubing Handpiece ReplacementEFB · Traditional | 03/06/1986SE |
| K831136 | Double Bow Tooth SeparatorJEP · Traditional | 06/08/1983SE |
Questions and answers
When was Tubing Syring cleared by the FDA?
Tubing Syring (K854699) received a 510(k) decision of Substantially Equivalent on January 6, 1986, 46 days after the submission was received.
What is the product code of K854699?
The FDA product code is ECB – Unit, Syringe, Air And/Or Water, a Class I (low risk) device regulated under 21 CFR 872.4565.