PLASDENT CORP.
Registration 2029234FEI 1000220911POMONA, CA
Owner/operator: PLASDENT CORP.
- Complaint File Establishment per 21 CFR 820.198
- Repack or Relabel Medical Device
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 27
- Added, last 12 months
- 0
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 27
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| PEM | Dental Barriers & SleevesDental Barriers And Sleeves | Class 2 | 21 CFR 878.4370 | K201604 |
| FXX | EARLOOP MASKS, FACE MASKSMask, Surgical | Class 2 | 21 CFR 878.4040 | K133070 |
| KHR | Tray Paper, Bib, Tissue Headrest Cover, Face & Chest CoverAbsorber, Saliva, Paper | Class 1 | 21 CFR 872.6050 | — |
| KXF | Cotton Tip Applicators, Micro Applicators, Applicator Tips, Microbrush ApplicatorsApplicator, Absorbent Tipped, Non-Sterile | Class 1 | 21 CFR 880.6025 | — |
| NRU | Chair, Chair stools & accessories, plastic covers, plastic tubing & sleeves, barrier films, plastic bagsChair, Dental, Without Operative Unit | Class 1 | 21 CFR 872.6250 | — |
| EFT | Denture CleanserCleanser, Denture, Over The Counter | Class 1 | 21 CFR 872.3520 | — |
| EFN | Cotton Rolls, cotton roll dispenser, cotton roll applicatorsCotton, Roll | Class 1 | 21 CFR 872.6050 | — |
| EHZ | EVACUATOR, ORAL CAVITY-EVACUATOR TIPS, HVE Tip Accessories, AdaptorsEvacuator, Oral Cavity | Class 1 | 21 CFR 872.6640 | — |
| JES | Dental FlossFloss, Dental | Class 1 | 21 CFR 872.6390 | — |
| NAB | GAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE-GAUZE/SPONGE, COTTON SPUNLACE SPONGESGauze / Sponge,Nonresorbable For External Use | Class 1 | 21 CFR 878.4014 | — |
| EJB | Valve, Snap on tips, Lever, SE Tip AccessoriesHandle, Instrument, Dental | Class 1 | 21 CFR 872.4565 | — |
| EGZ | Plastic Film Holder,Bite Block,Film carrier,Barrier envelopes, Aligning system,Snap film holder,Sensor holder,Film MountHolder, Film, X-Ray | Class 1 | 21 CFR 872.1905 | — |
and 15 more on your full dossier
What changed
Nothing added in the last twelve months, and no change seen on the record yet.