Perflex
IsraelFDA applicant, unverified FDA
Perflex is a medical device manufacturer, with 203 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) as of 12 Nov 2026.
- Devices
- 203
- Registrations
- FDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 202
- FDA 510(k) 1
- Device classes
- FDA Class II 199
- FDA Class I 4
At a glance
Market reach
- United States
- FDA establishment
What Perflex makes
Perflex manufactures thermoplastic materials and composite resins for dental appliance fabrication, including custom-fit dental impression materials and thermoplastic sheets for dental prosthetics. Their product line includes cartridges for dental impression materials, such as T-Crystal and FlexiNylon, as well as acrylic-free alternatives for dental aligners and retainers. These materials are designed for use in dental labs and clinical settings to create dental appliances like retainers, aligners, and bite guards.
The company’s products are regulated under FDA Class I and Class II classifications, with most devices authorised via the 510(k) pathway and listed in the FDA’s Unique Device Identifier (UDI) database. These materials are intended for dental use in the United States.
Catalogue
Search and filter all 203 devicesShowing 1-50 of 203
FDA establishments
- Perflex Ltd Netanya Central · IL FEI 3011532731
Frequently asked questions
How many devices does Perflex have in the registry?
The registry currently lists 203 devices for Perflex. Devices recorded under merged duplicate company entries are counted once.
Which registries list Perflex's devices?
Among its 50 most recently registered devices, Perflex has devices listed in FDA GUDID (50 devices).
What risk classes do Perflex's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Perflex's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Perflex in the registry?
The most recently registered devices listed for Perflex include Perflex Thermofix White, FlexiNylon Amhari/Purple Pink 200gr, Perflex AcryFree Clear 200gr. jar and T-Crystal cartridges Amhari/Purple Pink 28mm Diam. Medium 60mm long.
Which FDA establishments are linked to Perflex?
1 FDA establishment is linked to Perflex in the registry; they are listed on the company page.