Pulpdent Corp. of America
United StatesFDA applicant, unverified
- Devices
- 6
What Pulpdent Corp. of America makes
Pulpdent Corp. of America manufactures dental materials and instruments, including water-based setting agents like the POLYCARB WATER SET, periodontal dressings such as the PCA PERIOCARE, and fiber mesh for dental applications. Their portfolio also includes dental putties and regular/heavy-fill composites (e.g., BISICO SL, S2, S3), an apex locator (EVIDENT MARK 2), and acid etch gels for tooth preparation.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company is based in the United States and its products are listed in the FDA’s 510(k) registry.
Catalogue
Polycarb Water Set Ref K853447
Regimes: 510(k) Registry: 510(k)Pca Periocare Periodontal Dressing Ref K810545
Regimes: 510(k) Registry: 510(k)Fiber Mesh Ref K854977
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Evident Mark 2 Apex Locator Ref K863834
Regimes: 510(k) Registry: 510(k)Acid Etch Gel Ref K882576
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pulpdent Corp. of America have in the registry?
The registry currently lists 6 devices for Pulpdent Corp. of America. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pulpdent Corp. of America's devices?
Among its 6 most recently registered devices, Pulpdent Corp. of America has devices listed in FDA 510(k) (6 devices).
What risk classes do Pulpdent Corp. of America's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Pulpdent Corp. of America's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Pulpdent Corp. of America in the registry?
The most recently registered devices listed for Pulpdent Corp. of America include POLYCARB WATER SET, PCA PERIOCARE PERIODONTAL DRESSING, FIBER MESH and BISICO SL(PUTTY) BISICO S2(REGULAR) S3 HEAVY ETC..