Pro-Dex Inc
Irvine, CA, US
PRO-DEX, INC. appears in FDA device records in Irvine, CA. FDA records list no 510(k) clearances, no PMA records and 2 registered establishments. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Pro-Dex Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Pro-Dex Inc dba Dyna-Dentrecall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2081135 | 2081135 | PRO-DEX, INC. | 2361 McGaw Avenue, Irvine, CA 92614 US | 2026 | |
| 3024788684 | 3024788684 | Pro-Dex Inc | 14401 Franklin Ave, Tustin, CA 92780 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HRXArthroscope
- GFGBit, Surgical
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- GEYMotor, Surgical Instrument, Ac-Powered
- OLOOrthopedic Stereotaxic Instrument
- EMNScaler, Periodontic
- GXLScrewdriver, Skullplate
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- FSMTray, Surgical, Instrument
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0280-2025 | KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000 | The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package. | Class II | Open, Classified | |
| Z-2098-2023 | KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver | Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachment have switched manufacturing and expiration dates on sterile pouch labels, so batteries will appear to be prematurely expired. | Class II | Open, Classified | |
| Z-1391-2023 | KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter. | Incorrect Unique Device Identifier/GTIN code was used on product. | Class II | Open, Classified | |
| Z-2340-2019 | PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2 Product Usage: -The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the PDSD Surgical driver. There is only one PDSD Surgical driver currently being produced (PDSD-5000) and the battery only works to power this driver. -The PDSD Series surgical drivers are Pro-Dex Branded surgical fixation drivers meant to drive surgical screws into bone in the CMF region of the body. They are class I exempt (Product codes GEY/GXL) battery powered hand pieces with a fixed collet. The only accessory is the PDBP-001 battery. | Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers. | Class II | Terminated | |
| Z-1095-2016 | Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver). | The sterile battery may contain particulates within the sterile package. | Class II | Terminated | |
| Z-1094-2016 | Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver). | The sterile battery may contain particulates within the sterile package. | Class II | Terminated | |
| Z-1212-2010 | Zimmer PTW4321 20 Ncm Dental Torque Wrench, QTY 1 Pro-Dex Inc, Irvine, CA 92614 The Dental Torque Wrench is used to fasten dental implant abutments during the placement of dental implants. | Pro-Dex has initiated a recall on their Dental Torque Wrench. The recall was initiated due to an inaccurate laser etch identification of the torque value. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain