CMW Cement Pressurisation System
FDA 510(k) K897134 · Dentsply Intl.
510(k) numberK897134
Submission
- Device name
- CMW Cement Pressurisation System
- Applicant
- Dentsply Intl.
York, PA, US - Received
- December 27, 1989
- Decision date
- March 2, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KIH – Dispenser, Cement
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4200
- Specialty
- Orthopedic
Other 510(k)s with product code KIH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K042591 | Smartmix Pre-Filled Mixing SystemKIH · Special | DePuy Orthopaedics, Inc. | 10/22/2004SE |
| K943906 | P.F.C. Cement Pressurizing SystemKIH · Traditional | Johnson & Johnson Professionals, Inc. | 12/21/1994SE |
| K851881 | Orthopeadic Cement Delivery SystemKIH · Traditional | Dentsply Intl. | 06/13/1985SE |
| K840046 | Pressurizing/Scavenging Acrylic CementKIH · Traditional | Precision Medical Devices, Inc. | 02/09/1984SE |
| K833675 | Brigham Tibial Cement PressurizerKIH · Traditional | Howmedica Corp. | 12/12/1983SE |
| K811317 | Howmedica Femoral Pressuring SealKIH · Traditional | Howmedica Corp. | 05/29/1981SE |
| K801388 | Oh-HarrisKIH · Traditional | Johnson & Johnson Professionals, Inc. | 07/28/1980SE |
| K790275 | Gun, Exeter CementKIH · Traditional | Howmedica Corp. | 02/21/1979SE |
| K781955 | Gun, CementKIH · Traditional | Depuy, Inc. | 12/04/1978SE |
| K780266 | Bone Cement ApplicatorKIH · Traditional | Zimmer, Inc. | 02/28/1978SE |
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| K082198 | Durashield PlusLBH · Traditional | 10/29/2008SE |
| K072730 | Friadent Cercon and Ankylos Cercon Balance AbutmentsNHA · Traditional | 03/27/2008SE |
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Questions and answers
When was CMW Cement Pressurisation System cleared by the FDA?
CMW Cement Pressurisation System (K897134) received a 510(k) decision of Substantially Equivalent on March 2, 1990, 65 days after the submission was received.
What is the product code of K897134?
The FDA product code is KIH – Dispenser, Cement, a Class I (low risk) device regulated under 21 CFR 888.4200.