Plasdent.
Pomona, California, company whose FDA filing describes disposable barrier sleeves and barrier film for dental instruments.
- Dental Manufacturer
- USA
- Consumables
- Infection Control
About Plasdent
A December 2020 FDA 510(k) letter for K201604 lists the submitter as Plasdent Corporation, 969 Price Street, Pomona, California 91767, with Belen Walayat as corporate manager and telephone (909) 620-0289. The device name is Plasdent Disposable Barrier Sleeves and Barrier Film. The indications say the products are a disposable barrier for dental instruments and equipment, non-sterile, and for single-patient, one-time use.
The 510(k) summary says the sleeves and film are polyethylene and come in shapes meant to cover air-water syringes, curing lights, handpieces, sensors, trays, chairs, headrests, and X-ray heads. They are a physical cover. They are not a sterilizer and they are not a replacement for cleaning the instrument underneath. The predicate device named in the summary is a Pac-Dent barrier, K151123.
Business directories list a Pomona address at 1290 Price Avenue and a phone that matches the FDA number, and one directory says the company was founded in 1987. Those directory facts are not in the 510(k). Use 969 Price Street when you are quoting the regulatory file, and ask the company which dock is current before you ship a return. The catalog record on this site does not print a company website.
Older directory profiles also mention evacuators, masks, and disposable products. This profile does not invent SKUs beyond the barrier the FDA file describes and the evacuation category already associated with the brand. If you buy saliva ejectors or HVE tips, confirm they are Plasdent parts and that they fit the vacuum tubing you own. The 510(k) summary says sleeves cover small hand-held instruments and that film covers larger equipment, and that both are prepackaged. Staff should size the sleeve to the curing light or sensor before the patient is seated, because a loose cover defeats the point of a barrier. The letter's contact email in the summary is belengw@plasdent.com. Use the phone on the letter if that mailbox is no longer monitored. Directory pages that list masks and articulators are not the same as K201604. Ask for the catalog page that matches the SKU before you treat those categories as cleared devices. The summary also says the device is Class II under 21 CFR 878.4370, product code PEM, with a surgical-drape classification. That classification is why the labeling talks about a cover rather than about sterilization. Keep the 510(k) number with the purchasing file. The predicate named in the summary is Pac-Dent's barrier, K151123, which only shows the category. It does not mean the two companies' sleeves are the same size.
Key Offerings
Product and equipment lines dentists commonly associate with Plasdent.
Barrier sleeves
The K201604 summary says polyethylene sleeves cover hand-held items such as air-water syringes, curing lights, handpieces, and sensors. They are non-sterile and single use. They do not sterilize the instrument.
Barrier film
The same summary says film covers equipment such as chairs, headrests, and X-ray heads. Film is a surface cover for one patient. It is not a surface disinfectant.
Evacuation disposables
Directory profiles and this site's existing category place evacuators with Plasdent. The FDA file reviewed here does not list those tips. Confirm the part number and the tubing size before you standardize a tip.
Single-use infection covers
The indications limit the cleared barrier to one patient and one use. Reusing a sleeve because it looks clean is outside the labeling in K201604.
Who Plasdent suits
Plasdent suits a practice buying disposable covers for instruments and equipment, and checking whether evacuation tips from the same seller fit the vacuum system. Vacuum equipment is compared on the dental vacuum guide.
A barrier is not the vacuum pump and not the sterilizer. Keep those purchases separate.
Cover versus clean
The FDA file says the barrier is non-sterile. Staff still clean and, when required, sterilize the instrument. The sleeve is discarded after the patient.
The predicate comparison in the 510(k) is to another barrier film, not to a clinical outcome. Do not read K201604 as a study of infection rates.
Pomona contact
The regulatory address is 969 Price Street, Pomona, CA 91767, phone (909) 620-0289. A directory lists 1290 Price Avenue with the same phone. Confirm the ship-from door.
Ask for the current IFU for the sleeve size that fits your curing light or sensor. Shapes differ.
Questions buyers ask
Where is Plasdent?
The 2020 FDA 510(k) lists Plasdent Corporation at 969 Price Street, Pomona, California 91767, and phone (909) 620-0289. A business directory lists 1290 Price Avenue in the same city.
What did the FDA clear?
K201604 clears Plasdent Disposable Barrier Sleeves and Barrier Film as a non-sterile, single-patient cover for dental instruments and equipment. The summary says they are polyethylene film.
Do the sleeves sterilize instruments?
No. The indications describe a physical barrier for one use. Cleaning and sterilization of the instrument follow the instrument manufacturer's instructions, not the sleeve.
Which guide is the closest category?
Evacuation products connect to the practice vacuum. See the dental vacuum guide for the equipment side, and read the Plasdent label for the disposable itself.