BATTERY PACK, KLS-SD-2000, SINGLE - KLS-BP2-001
2022-03-29
PRO-DEX, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2081135 | 2081135 | PRO-DEX, INC. | 1 | N | 2026-01-01 | 2361 McGaw Avenue Irvine CA US 92614 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 5327 | 1986055412 | K993535 | METAPAK MULTI-PURPOSE INSTRUMENT TRAY | FRG | 2001-12-07 |
| 5327 | 1335409172 | K896879 | ORAL SURGERY HANDPIECE AND ATTACHMENTS | EFB | 1990-03-07 |
| 5327 | 1884443099 | K896878 | HANDPIECE SYSTEM WITH MOTOR (SEVERAL MODELS) | EFB | 1990-03-08 |
| 5327 | 1809714750 | K896877 | DENTAL AIR MOTORS (SEVERAL MODELS) | EFB | 1990-03-07 |
| 5327 | 1080221754 | K896876 | DYNATORQ DENTAL HANDPIECE ATTACHMENTS | EFB | 1990-03-07 |
| 5327 | 1352746418 | K012105 | POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM | KCT | 2002-08-02 |
| 5327 | 1092495881 | ||||
| 5327 | 1559363074 | ||||
| 5327 | 1909051709 | ||||
| 5327 | 1214073694 | ||||
| 5327 | 1277897085 | ||||
| 5327 | 1509582885 | ||||
| 5327 | 1532697057 | ||||
| 5327 | 1654473311 | ||||
| 5327 | 1742573017 | ||||
| 5327 | 2012862317 | ||||
| 5327 | 2029285815 |
Product Codes Associated With Registrations#
GUDID#
MatrixPro Sterilization Case Lid - 60.000.011
2022-03-28
Pro-Dex CMF Surgical Driver (AXS™ NEURO DRIVER) - PDCMF-1000-1
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Battery Pack, Single Use, PDCMF, Tadiran - PDCMF-BP-001
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KLS E-Coupling Adapter - PDEC-1000-3
2022-03-29
KLS MaxDriver 2 - KLS-SD-2000
2022-03-29
Pro-Dex Surgical Driver - PDSD-5000-1
2022-03-29
Pro-Dex Surgical Driver AO Collet - PDSD-5000-2
2022-03-29
Pro-Dex Surgical Driver Custom Collet - PDSD-5000-5
2022-03-29
ProDriver Battery Pack, Single - PDBP-001-2
2022-03-29
MatrixPRO Driver Battery Pack, Sterile - 05.000.021S
2022-03-23
Atlas Pro Driver Battery Pack, Sterile - APD-BP-001S-1
2020-03-13
MatrixPro sterilization case - 60.000.010
2020-03-27
Matrix Pro II Graphics case - 60.000.015
2020-03-11
Zimmer Biomet Atlas Pro Driver - APD-1000-4
2023-06-09
MatrixPRO II Handpiece Loaner - 05.000.030LN
2022-04-01
MatrixPRO Driver Loaner - 05.000.020LN
2022-04-01
Pro-Dex Surgical Driver Medicon - PDSD-5000-6
2022-03-29
KLS Martin Surgical Driver, Non-Torque Limiting - KLS-SD-1000-NTL
2022-03-29
KLS MARTIN SURGICAL DRIVER - KLS-SD-1000
2022-03-28
Atlas Pro Driver - APD-1000-1
2022-03-28
MatrixPRO driver Handpiece - 05.000.020
2020-03-27
Matrix Pro II Driver - 05.000.030
2020-03-12
Zimmer Biomet 90D Atlas Blade - APD-B90-201
2023-06-13
Zimmer Biomet Atlas Pro-Driver Battery, Single Use - APD-BP-001S-4
2023-10-26
Zimmer Biomet Atlas Pro Driver Sterilization Container - APD-SC-003
2023-06-09
Zimmer Biomet 90D Collet - APD-CA-301
2023-06-09
Zimmer Biomet Straight Collet - APD-CA-005
2023-06-09
BATTERY PACK, KLS-SD-1000, SINGLE - KLS-BP-001
2022-03-29
Sterilization Case, PDCMF (AXS™ NEURO DRIVER Storage and Transport Tray) - PDCMF-SC-001
2022-04-01
Atlas Pro Driver Sterilization Case - APD-SC-001
2022-03-29
Atlas Pro Driver Collet Attachment Hex - APD-CA-001-1
2022-03-28
Matrix Pro II Single Use Battery - 05.000.031S
2020-03-16
Matrix Pro II Hex collet - 03.000.500
2020-03-13
Matrix Pro II J-latch collet - 03.000.501
2020-03-13
Matrix Pro II 90D Collet, Short - 03.000.502
2020-03-13
Matrix Pro II 90D Collet, long - 03.000.503
2020-03-13
KLS E-Coupling Adapter - PDEC-1000-2
2023-05-23
BATTERY PACK, KLS-SD-2000, SINGLE - KLS-BP2-001
2022-03-29
BATTERY PACK, KLS-SD-1000, SINGLE - KLS-BP-001
2022-03-29