FDA Device Registration & Listing · Sialkot Punjab, PK · Registration 3013946322
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| ECT | Driver, Band, Orthodontic | Dental | Class 1 | 872.4565 | 2023-01-24 |
| EMG | Forceps, Tooth Extractor, Surgical | Dental | Class 1 | 872.4565 | 2018-11-20 |
| DYJ | Retainer, Screw Expansion, Orthodontic | Dental | Class 1 | 872.5410 | 2023-01-24 |
| EAX | Mirror, Mouth | Dental | Class 1 | 872.4565 | 2021-04-06 |
| HXJ | Staple Driver | Orthopedic | Class 1 | 888.4540 | 2023-01-24 |
| EIG | Retractor, All Types | Dental | Class 1 | 872.4565 | 2021-04-06 |
| LRY | Punch, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2021-04-06 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2021-04-06 |
| NJZ | Extractor, Vein | General, Plastic Surgery | Class 1 | 878.4800 | 2023-01-24 |
| IDZ | Cassettes, Tissue | Pathology | Class 1 | 864.3010 | 2021-04-06 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2021-04-06 |
| HXZ | Cutter, Wire | Orthopedic | Class 1 | 888.4540 | 2021-04-06 |
| KCX | Epilator, High Frequency, Tweezer-Type | General, Plastic Surgery | Class 1 | 878.5360 | 2021-04-06 |
| KIL | Positioner, Socket | Orthopedic | Class 1 | 888.4540 | 2023-01-24 |
| EMI | File, Bone, Surgical | Dental | Class 1 | 872.4565 | 2021-04-06 |
| EMD | Hemostat, Surgical | Dental | Class 1 | 872.4565 | 2021-04-06 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 2021-04-06 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2021-04-06 |
| HRQ | Hemostat | General, Plastic Surgery | Class 1 | 878.4800 | 2021-04-06 |
| GFJ | Mallet, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2018-12-07 |
| GFC | Driver, Surgical, Pin | General, Plastic Surgery | Class 1 | 878.4820 | 2023-01-24 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2018-11-19 |
| EKR | Plugger, Root Canal, Endodontic | Dental | Class 1 | 872.4565 | 2021-04-06 |
| EHY | Tray, Impression, Preformed | Dental | Class 1 | 872.6880 | 2018-12-07 |
| EJL | Bur, Dental | Dental | Class 1 | 872.3240 | 2021-04-06 |
| EJX | Anchor, Preformed | Dental | Class 1 | 872.3130 | 2023-01-24 |
| HTC | Pliers, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2021-04-06 |
| EMK | Curette, Surgical, Dental | Dental | Class 1 | 872.4565 | 2021-04-06 |
| EMJ | Elevator, Surgical, Dental | Dental | Class 1 | 872.4565 | 2021-04-06 |
| HTE | Elevator | General, Plastic Surgery | Class 1 | 878.4800 | 2018-11-20 |
| EMN | Scaler, Periodontic | Dental | Class 1 | 872.4565 | 2018-11-20 |
| EIS | Remover, Crown | Dental | Class 1 | 872.4565 | 2021-04-06 |
| LYS | Bone Mill | Orthopedic | Class 1 | 888.4540 | 2018-12-07 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2021-04-06 |
| NDP | Accessories, Implant, Dental, Endosseous | Dental | Class 1 | 872.3980 | 2021-04-06 |
| KMY | Positioner, Tooth, Preformed | Dental | Class 1 | 872.5525 | 2023-01-24 |
| FTX | Mirror, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2021-04-06 |
| EIC | Syringe, Periodontic, Endodontic, Irrigating | Dental | Class 1 | 872.4565 | 2021-04-06 |
| KCB | Tube, Tonsil Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2021-04-06 |
| LRZ | Screwdriver, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2021-04-06 |
| KBB | Rongeur, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2021-04-06 |
| EJE | Frame, Rubber Dam | Dental | Class 1 | 872.6300 | 2021-04-06 |
| EKB | Explorer, Operative | Dental | Class 1 | 872.4565 | 2021-04-06 |
| EBR | Unit, Suction Operatory | Dental | Class 1 | 872.6640 | 2018-11-26 |
| EML | Chisel, Bone, Surgical | Dental | Class 1 | 872.4565 | 2021-04-06 |
| HWB | Extractor | Orthopedic | Class 1 | 888.4540 | 2023-01-24 |
| GFI | Osteotome, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2021-04-06 |
| EMF | Knife, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2021-04-06 |
| HWK | Trephine | Orthopedic | Class 1 | 888.4540 | 2021-04-06 |
| HXX | Screwdriver | Orthopedic | Class 1 | 888.4540 | 2021-04-06 |
| LXI | Guide, Drill, Ligament | General, Plastic Surgery | Class 1 | 878.4820 | 2023-01-24 |
| EJI | Syringe, Cartridge | Dental | Class 2 | 872.6770 | 2023-01-24 |
| EGN | Scissors, Surgical Tissue, Dental | Dental | Class 1 | 872.4565 | 2018-11-20 |
| EEF | Clamp, Rubber Dam | Dental | Class 1 | 872.6300 | 2021-04-06 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K852723 | The Huxley Instrument Corp. | FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420 | 1985-07-15 |
| K873512 | Arthropedics, Inc. | SERRATED GRASPING FORCEPS, RIGHT | 1987-11-02 |
| K851721 | Artiberia | 1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS | 1985-07-02 |
| K821275 | Conphar, Inc. | MAYO SCISSOR STRAIGHT 5 1/2 | 1982-05-28 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0039-2018 | Teleflex Medical | 1 | Pilling Knife Handles:
a) REF 352950
b) REF 352953
c) REF 352951
d) REF 352957
e) REF 352952 :
Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle. |
| Z-0027-2016 | Zimmer, Inc. | 1 | Zimmer Universal Locking System, Titanium 3.5mm.
Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices. |
| Z-0013-2022 | Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel | 1 | Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. |
| Z-0014-2022 | Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel | 1 | Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. |
| Z-0015-2022 | Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel | 1 | Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3009171220 | DENTIMED SAO JOAO | Sunrise, FL, US |
| 3009827000 | WHITE OAK ORTHODONTIC PRODUCTS | Mount Joy, PA, US |
| 3015060193 | CHENGDU SANI MEDICAL EQUIPMENT CO.,LTD. | Chengdu Sichuan, CN |
| 3009551666 | SURGIDENT CO., LTD. | Dong-gu Daegu, KR |
| 1937100 | Ortho Solutions LC | Lake Saint Louis, MO, US |
3013946322 when referencing this establishment in official correspondence.