Ei Downpak Barrier Sleeves
FDA 510(k) K073369 · Hu-Friedy Mfg. Co., Inc.
510(k) numberK073369
Submission
- Device name
- Ei Downpak Barrier Sleeves
- Applicant
- Hu-Friedy Mfg. Co., Inc.
Chicago, IL, US - Received
- November 30, 2007
- Decision date
- February 27, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EKM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070246 | Down PakEKM · Special | Endo Twinn B.V. | 02/16/2007SE |
| K051573 | TGP (Gutta Percha Containing Tetracycline or Doxycycline)EKM · Traditional | Dr. Howard Martin, P.A. | 06/26/2006SE |
| K042870 | Endo TwinnEKM · Traditional | Endo Twinn B.V. | 01/11/2005SE |
| K023819 | Fiberfill SGPEKM · Traditional | Pentron Clinical Technologies | 03/26/2003SE |
| K971641 | Antibacterial Gutta PerchaEKM · Traditional | Dr. Howard Martin, P.A. | 07/21/1997SE |
| K970134 | Thermaprep Plus OvenEKM · Traditional | Tulsa Dental Products, Ltd. | 03/21/1997SE |
| K931742 | Inject-R FillEKM · Traditional | Union Broach, Div. Moyco Industries, Inc. | 05/27/1993SE |
| K924825 | Microdose Rc-EzEKM · Traditional | Unicep | 03/05/1993SE |
| K915243 | Touch 'N Heat Model 5002, ModificationEKM · Traditional | Analytic Technology | 01/21/1992SE |
| K910224 | ThermaprepEKM · Traditional | Tulsa Dental Products, Ltd. | 03/29/1991SE |
More from Tulsa Dental Products, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K120659 | Hu-Friedy Dental Cartridge SyringeEJI · Traditional | 11/06/2012SE |
| K100401 | Swerv Magnetostrictive Ultrasonic Scaler SystemELC · Traditional | 03/30/2010SE |
| K070975 | Symmetry Iq, Model 2000 Series, 3000 SeriesELC · Traditional | 06/21/2007SE |
| K053178 | Symmetry S-Series Piezoelectric Scaling TipsELC · Traditional | 02/01/2006SE |
| K012060 | Modification To:Hu-Friedy Brand Satin Swivel Ultrasonic InsertELC · Special | 07/27/2001SE |
| K953919 | Dental Ultrasonic Scaler InsertsELC · Traditional | 10/07/1995SE |
| K912473 | Accu-Placer TM KitEKJ · Traditional | 07/24/1991SE |
| K844002 | Hu-Friedy Ims Cassette SystemFSM · Traditional | 11/08/1984SE |
Questions and answers
When was Ei Downpak Barrier Sleeves cleared by the FDA?
Ei Downpak Barrier Sleeves (K073369) received a 510(k) decision of Substantially Equivalent on February 27, 2008, 89 days after the submission was received.
What is the product code of K073369?
The FDA product code is EKM – Gutta-Percha, a Class I (low risk) device regulated under 21 CFR 872.3850.