Axis System
FDA 510(k) K072989 · Dentsply Intl., Inc.
510(k) numberK072989
Submission
- Device name
- Axis System
- Applicant
- Dentsply Intl., Inc.
York, PA, US - Received
- October 23, 2007
- Decision date
- January 28, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K140347 | Ankylos C/X Implant SystemDZE · Traditional | 08/20/2014SE |
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| 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 |
| K073117 | Dentin Desensitizer AgentLBH · Traditional | 12/19/2007SE |
| K070538 | XP Bond Dual Cure Universal Total Etch AdhesiveKLE · Special | 03/14/2007SE |
Questions and answers
When was Axis System cleared by the FDA?
Axis System (K072989) received a 510(k) decision of Substantially Equivalent on January 28, 2008, 97 days after the submission was received.
What is the product code of K072989?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.