Reusable Bowl and Spatula for Mixing Bone Cements
FDA 510(k) K892937 · Dentsply Intl.
510(k) numberK892937
Submission
- Device name
- Reusable Bowl and Spatula for Mixing Bone Cements
- Applicant
- Dentsply Intl.
York, PA, US - Received
- April 21, 1989
- Decision date
- June 22, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JDZ – Mixer, Cement, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4210
- Specialty
- Orthopedic
Other 510(k)s with product code JDZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K934253 | Exactech All Poly Acetabular CupJDZ · Traditional | Exactech, Inc. | 04/29/1994SE |
| K925025 | Prism Bone Cement Mixing SystemJDZ · Traditional | Depuy, Inc. | 01/05/1994SE |
| K912190 | Stryker High Vacuum Bone Cement Mixer/Inject SystJDZ · Traditional | Stryker Corp. | 08/29/1991SE |
| K861086 | Zimmer Vacuum Mixing SystemJDZ · Traditional | Zimmer, Inc. | 04/14/1986SE |
| K854077 | Mix Evac IIJDZ · Traditional | Stryker Corp. | 01/31/1986SN |
| K853310 | Simplex Enhancement MixerJDZ · Traditional | Howmedica Corp. | 09/11/1985SE |
| K851205 | CementrifugeJDZ · Traditional | Biodynamic Technologies, Inc. | 07/16/1985SE |
| K843219 | Zimmer Bone Cement Centrifugation SysJDZ · Traditional | Zimmer, Inc. | 11/29/1984SE |
| K792186 | Howmedica Mix-Kit IIJDZ · Traditional | Howmedica Corp. | 12/05/1979SE |
| K780857 | Mixing Bowl & Spatula, DisposableJDZ · Traditional | Howmedica Corp. | 06/13/1978SE |
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| K123615 | Iris - High Strength Glass CeramicEIH · Traditional | 02/22/2013SE |
| K103244 | Qmix 2IN1 Endodontic Irrigating SolutionKJJ · Traditional | 02/14/2011SE |
| K093221 | Pre-Cemented Orthodontic Bracket System Extension IIDYH · Special | 10/30/2009SE |
| K083805 | Ankylos C/X Dental Implant SystemDZE · Traditional | 05/22/2009SE |
| K082198 | Durashield PlusLBH · Traditional | 10/29/2008SE |
| K072730 | Friadent Cercon and Ankylos Cercon Balance AbutmentsNHA · Traditional | 03/27/2008SE |
| K072989 | Axis SystemEFB · Traditional | 01/28/2008SE |
| K073117 | Dentin Desensitizer AgentLBH · Traditional | 12/19/2007SE |
Questions and answers
When was Reusable Bowl and Spatula for Mixing Bone Cements cleared by the FDA?
Reusable Bowl and Spatula for Mixing Bone Cements (K892937) received a 510(k) decision of Substantially Equivalent on June 22, 1989, 62 days after the submission was received.
What is the product code of K892937?
The FDA product code is JDZ – Mixer, Cement, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 888.4210.