Is this your brand? Sign in to claim ownership.

Sientra, Inc.

Last updated May 24, 2026

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. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: —
Website: sientra.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 888-708-0808
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 010209877

Catalogue (1489)

Page 15 of 30

Device	Model / Reference	Registries	Class	Status
SIENTRA Silicone Gel Breast Implant Sizer	GS10621-155MP	FDA UDI	U	Active
Softspan Tissue Expander	SRE-CR-200	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10712-210MP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10610-060LP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	10721-650MP	FDA UDI	Class III	Active
SIENTRA Calf Implant	402-260U	FDA UDI	Class II	Unknown
SIENTRA Silicone Gel Breast Implant	20612-470MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	10621-455MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20645-500MP	FDA UDI	Class III	Unknown
SIENTRA Silicone Gel Breast Implant	20676-180MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20710-160LP	FDA UDI	Class III	Active
SIENTRA Tissue Expander	820-100U3	FDA UDI	U	Unknown
SIENTRA Silicone Gel Breast Implant	20610-650LP	FDA UDI	Class III	Active
SIENTRA Gluteal Implant	20942-145U	FDA UDI	Class II	Unknown
SIENTRA Tissue Expander	819-800U	FDA UDI	U	Unknown
Silicone Gel Sizer	GSOBASE-400HP	FDA UDI	Class III	Active
Silicone Gel Sizer	GSCBASE-485HP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10610-600LP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	10512-100MP	FDA UDI	Class III	Unknown
Softspan Tissue Expander	SIE-LR-126S	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	20645-700LP	FDA UDI	Class III	Active
Softspan Tissue Expander	BTE1200	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10721-510XP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10712-190MP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10721-340XP	FDA UDI	U	Active
OPUS Silicone Gel Breast Implant	CBASE-570HP	FDA UDI	Class III	Active
OPUS Silicone Gel Breast Implant	RBASE-205MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10512-270MP	FDA UDI	U	Active
Silicone Gel Sizer	GSOBASE-475MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	10621-620HP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20612-425MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10610-440LPP	FDA UDI	U	Active
SIENTRA Tissue Expander	810-250U3	FDA UDI	U	Unknown
SIENTRA Silicone Gel Breast Implant Sizer	GS10721-800MP	FDA UDI	U	Active
Softspan Tissue Expander	VU-ATE-450	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	20645-700MP	FDA UDI	Class III	Unknown
SIENTRA Silicone Gel Breast Implant Sizer	GS10721-445XP	FDA UDI	U	Active
OPUS Silicone Gel Breast Implant	10712-510MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10721-415MP	FDA UDI	U	Active
Softspan Tissue Expander	SRE-LR-250S	FDA UDI	U	Active
Softspan Tissue Expander	SHR-LR-075S	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	10512-230MP	FDA UDI	Class III	Active
Dermaspan Tissue Expander	LPP-FH13-R	FDA UDI	U	Active
SIENTRA Tissue Expander	800-200U3	FDA UDI	U	Unknown
SIENTRA Silicone Gel Breast Implant	10710-550LP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	10521-335HP	FDA UDI	Class III	Unknown
SIENTRA Silicone Gel Breast Implant	10512-425MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	10621-535HP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10721-190XP	FDA UDI	U	Active
SIENTRA Tissue Expander	800-300U3	FDA UDI	U	Unknown

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.