Sientra, Inc.
United StatesFDA applicant, unverified
Sientra, Inc. is a medical device manufacturer, with 1,489 devices listed in FDA GUDID and FDA 510(k) (FDA Class III, Unclassified, Class II and Class I) as of 13 Nov 2026.
- Devices
- 1,489
Registry facts
- Registries
- FDA GUDID 1,487
- FDA 510(k) 2
- Device classes
- FDA Class III 903
- FDA Unclassified 516
- FDA Class II 59
- FDA Class I 11
- Identifiers
- DUNS 010209877
What Sientra, Inc. makes
The company manufactures silicone gel-filled breast implants with textured and smooth surfaces, including devices designed for breast reconstruction and augmentation. It also produces skin-port tissue expanders for gradual tissue preparation and single-use invasive breast implant sizers for preoperative assessment. Additional products include tissue expander injection port locators to aid in surgical planning.
These devices are classified as Class III under FDA regulations, requiring premarket approval for most implants, while tissue expanders fall under Class II (Class U for certain custom devices). The portfolio is listed in the FDA’s Unique Device Identifier (UDI) database.
Catalogue
Search and filter all 1,489 devicesShowing 1-50 of 1,489
Company details
- DUNS number
- 010209877
- Phone
- 888-708-0808
Frequently asked questions
How many devices does Sientra, Inc. have in the registry?
The registry currently lists 1489 devices for Sientra, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sientra, Inc.'s devices?
Among its 50 most recently registered devices, Sientra, Inc. has devices listed in FDA GUDID (50 devices).
What risk classes do Sientra, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Sientra, Inc.'s devices are Class I and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Sientra, Inc. in the registry?
The most recently registered devices listed for Sientra, Inc. include OPUS Silicone Gel Breast Implant RBASE-295HP, OPUS Silicone Gel Breast Implant CBASE-320HP, Silicone Gel Breast Implant OBASE-330MP and SIENTRA Silicone Gel Breast Implant 20676-550MP.