Pennwalt Corp.
United StatesFDA applicant, unverified
- Devices
- 6
What Pennwalt Corp. makes
Pennwalt Corp. manufactures dental and dental laboratory devices, including calcium hydroxide-based dental materials like pit sealants, portable pneumatic calibrators for dental equipment, and dental X-ray units such as the Panorex II. Their portfolio also includes radiographic film processing systems and dental radiography devices like the XR-710.
The company’s devices are classified under FDA categories Class I and Class II, with regulatory submissions recorded in the FDA’s 510(k) clearance database. Their products are listed in the United States under the jurisdiction of the FDA.
Catalogue
S.S. White-Pennwalt Renew Calcium Hydrox Ref K801860
Regimes: 510(k) Registry: 510(k)Portable Pneumatic Calibrator 65-150 Ref K780981
Regimes: 510(k) Registry: 510(k)Xr-710 Ref K800063
Regimes: 510(k) Registry: 510(k)Panorex Ii Dental X-Ray Unit Ref K800133
Regimes: 510(k) Registry: 510(k)Intrex Ref K833241
Regimes: 510(k) Registry: 510(k)S.S. White-Pennwalt Prelude Pit Sealant Ref K801274
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pennwalt Corp. have in the registry?
The registry currently lists 6 devices for Pennwalt Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pennwalt Corp.'s devices?
Among its 6 most recently registered devices, Pennwalt Corp. has devices listed in FDA 510(k) (6 devices).
What risk classes do Pennwalt Corp.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Pennwalt Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Pennwalt Corp. in the registry?
The most recently registered devices listed for Pennwalt Corp. include S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX, PORTABLE PNEUMATIC CALIBRATOR 65-150, XR-710 and PANOREX II DENTAL X-RAY UNIT.