PRESSX ZR
FDA 510(k) clearance K070772 · decided 2007-04-30
Clearance details
- K-number
- K070772
- Device name
- PRESSX ZR
- Applicant
- Wieland Dental + Technik GmbH & Co. KG
- Decision
- Substantially Equivalent
- Date received
- 2007-03-21
- Decision date
- 2007-04-30
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- EIH
- Device class
- 2
- Regulation number
- 872.6660
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Pforzheim, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.