Data / Medical devices / United States / Plasdent Corp.
Plasdent Corp.: FDA-registered device maker in Pomona, CA, United States, 2 510(k) clearances
Plasdent Corp. is registered with the FDA (registration 2029234) in Pomona, CA, United States. It lists 27 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 23, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2029234
- FEI number
- 1000220911
- Address
- 969 Price ST., Pomona, CA, United States, 91767
- Owner or operator
- PLASDENT CORP. (9010801)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- June 28, 1994
- Registered through
- 2027
- Brand names listed
- Chair, Chair stools & accessories, plastic covers, plastic tubing & sleeves, barrier films, plastic bags, Cheek Retractors, Props, Retractor-all types, Cotton Rolls, cotton roll dispenser, cotton roll applicators, Cotton Tip Applicators, Micro Applicators, Applicator Tips, Microbrush Applicators, DENTAL ACCESSORIES,Oral cup,Water Bottle,Vacuum Canister,Mixing Tip,Plastic Boxes,Matrices,Aligner Seater,Connector, DENTAL NEEDLE TIPS, BENT NEEDLE TIPS, IRRIGATION NEEDLE TIPS, Dam frame,overglove,Barrier apron,Waste bag,Inserts,Capsule applier,Brush handle& tips,Finger ruler,Matrix,Splash shield, Dental Barriers & Sleeves and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Absorber, Saliva, Paper | KHR | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Chair, Dental, Without Operative Unit | NRU | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Cleanser, Denture, Over The Counter | EFT | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Cotton, Roll | EFN | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Dental Barriers And Sleeves | PEM | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Evacuator, Oral Cavity | EHZ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Floss, Dental | JES | 1 | Repackager or relabeler | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Holder, Film, X-Ray | EGZ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Mouthpiece, Saliva Ejector | DYN | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Needle, Dental | DZM | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Pick, Massaging | JET | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Protector, Dental | BRW | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Syringe, Restorative And Impression Material | EID | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Unit, Operative Dental, Accessories | NRD | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Unit, Syringe, Air And/Or Water | ECB | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 23, 2020 | K201604 | Plasdent Disposable Barrier Sleeves and Barrier Film | PEM | Substantially Equivalent | Plasdent Corporation | accessdata.fda.gov |
| June 22, 2015 | K133070 | SURGICAL FACE MASK (Ear Loops and Tie-on) | FXX | Substantially Equivalent | Bh Medical Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Mask, Surgical
- All makers of Holder, Film, X-Ray
- All makers of Absorber, Saliva, Paper
- All makers of Evacuator, Oral Cavity
- All makers of Retractor, All Types
- All makers of Toothbrush, Manual
Updated December 23, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.