FDA Medical Device Recalls (openFDA)
Stardental Division: Solara Replacement Turbine, Autochuck End Cap, for dental handpiece, part number 064900.
- Recall number
- Z-0313-2007
- Recalling firm
- Stardental Division
- Product
- Solara Replacement Turbine, Autochuck End Cap, for dental handpiece, part number 064900.
- Status
- Terminated
- Initiated
- 2006-12-01
- Posted
- 2006-12-27
- Terminated
- 2007-06-12
- Reason
- End cap component can disassemble.
- Root cause
- Other
- Action
- The recalling firm sent recall letters to dealers and doctors via certified mail, return receipt on 12/6/06. Letters to the foreign accounts were sent via UPS or other traceable methods.
- Quantity
- 2756 end caps
- Distribution
- Worldwide distribution, including USA, Canada and Japan.
- Lot, serial or model codes
- Part number 064900, Lot numbers 1694789, 1697998, 1699566, and 1703516.0
- 510(k) numbers
- ["K960507","K960719"]
- PMA numbers
- not on file
- Product code
- EFA
- Firm FEI
- 2520265
- Firm city
- Lancaster
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28