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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 18 of 30

Device	Model / Reference	Registries	Class	Status
SIENTRA Silicone Gel Breast Implant	20621-285MP	FDA UDI	Class III	Active
OPUS Silicone Gel Breast Implant	RBASE-235HP	FDA UDI	Class III	Active
Softspan Tissue Expander	SIE-FO-86	FDA UDI	U	Active
Softspan Tissue Expander	SRE-RD-500S	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10610-250LP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	20721-285MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	10610-210LPP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10610-800LP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10621-420XP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	20621-590MP	FDA UDI	Class III	Active
Softspan Tissue Expander	SIE-FO-76	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	10610-280LPP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	10710-185LPP	FDA UDI	Class III	Active
SIENTRA Chin Implant	15-080U	FDA UDI	Class II	Unknown
SIENTRA Silicone Gel Breast Implant Sizer	GS10621-540MP	FDA UDI	U	Active
Silicone Gel Sizer	GSOBASE-600HP	FDA UDI	Class III	Active
Silicone Gel Sizer	GSOBASE-320LP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20646-205MP	FDA UDI	Class III	Unknown
SIENTRA Silicone Gel Breast Implant Sizer	GS10621-505HP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	20646-550HP	FDA UDI	Class III	Active
OPUS Silicone Gel Breast Implant	20721-340XP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10721-385HP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10721-620HP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10512-510MP	FDA UDI	U	Active
OPUS Silicone Gel Breast Implant	CBASE-425MP	FDA UDI	Class III	Active
Silicone Gel Sizer	GSRBASE-320HP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10621-350HP	FDA UDI	U	Active
Softspan Tissue Expander	SIE-LR-157	FDA UDI	U	Active
Softspan Tissue Expander	SHR-LR-500S	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10621-750MP	FDA UDI	U	Active
AlloX2 Tissue Expander	AlloX2-16SE	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10512-470MP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10512-170MP	FDA UDI	U	Active
Softspan Tissue Expander	SIE-CR-350S	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	20676-215HP	FDA UDI	Class III	Unknown
SIENTRA Silicone Gel Breast Implant	20621-385HP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	10521-570HP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20612-700MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20721-385MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	10621-650MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20676-400E	FDA UDI	Class III	Unknown
SIENTRA Silicone Gel Breast Implant	20710-450LP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20676-510HP	FDA UDI	Class III	Unknown
SIENTRA Silicone Gel Breast Implant	10610-190LP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	10512-320MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20710-140LP	FDA UDI	Class III	Active
OPUS Silicone Gel Breast Implant	10712-270MP	FDA UDI	Class III	Active
SIENTRA Chin Implant	15-065U	FDA UDI	Class II	Unknown
SIENTRA Silicone Gel Breast Implant	10610-100LP	FDA UDI	Class III	Unknown
SIENTRA Silicone Gel Breast Implant	10521-435HP	FDA UDI	Class III	Unknown

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