Sterling Drug, Inc.
United StatesFDA applicant, unverified
- Devices
- 9
What Sterling Drug, Inc. makes
Sterling Drug, Inc. manufactures dental and surgical barrier membranes, including resorbable and non-resorbable options like BIOBRANE II, used in periodontal and bone regeneration procedures. Their portfolio also includes contrast media warmers for pharmaceutical applications, sterile syringe adapters like the EMPTY STERILE CARPUJECT, and dental implants such as PERIOGRAF and ALVEOGRAF DURAPATITE cones for guided bone regeneration. Additional products include radiographic contrast media accessories like the DILUTION SPIKE and dental implant materials like PERIOGRAF DURAPATITE.
The company’s devices are regulated under FDA Class I, Class II, and Unclassified (U) classifications, with many authorised via the 510(k) pathway. Products are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.
Catalogue
Periograf Ref K813070
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Alveograf Durapatite(18-40 Mesh) Ref K813257
Regimes: 510(k) Registry: 510(k)Periograf Durapatite 40-60 Mesh Ref K840260
Regimes: 510(k) Registry: 510(k)Empty Sterile Carpuject Ref K820164
Regimes: 510(k) Registry: 510(k)Biobrane(R) Ii Ref K896110
Regimes: 510(k) Registry: 510(k)Conagraf Tm Durapatite Cones Ref K820023
Regimes: 510(k) Registry: 510(k)Dilution Spike Ref K780209
Regimes: 510(k) Registry: 510(k)Winthrop Pharmaceuticals Contrast Media Warmer Ref K875275
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sterling Drug, Inc. have in the registry?
The registry currently lists 9 devices for Sterling Drug, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sterling Drug, Inc.'s devices?
Among its 9 most recently registered devices, Sterling Drug, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do Sterling Drug, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Sterling Drug, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sterling Drug, Inc. in the registry?
The most recently registered devices listed for Sterling Drug, Inc. include PERIOGRAF, GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II, ALVEOGRAF DURAPATITE(18-40 MESH) and PERIOGRAF DURAPATITE 40-60 MESH.