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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 30 of 30

Device	Model / Reference	Registries	Class	Status
Softspan Tissue Expander	SIE-LR-157S	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10712-080MP	FDA UDI	U	Active
SIENTRA Vaginal Stent	3521-140U	FDA UDI	Class II	Unknown
Silicone Gel Sizer	GSOBASE-510HP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10610-340LP	FDA UDI	U	Active
Silicone Gel Sizer	GSCBASE-285HP	FDA UDI	Class III	Active
Softspan Tissue Expander	SHR-LR-150S	FDA UDI	U	Active
SIENTRA Gluteal Implant	20922-155U	FDA UDI	Class II	Unknown
Softspan Tissue Expander	SPR250	FDA UDI	U	Active
Dermaspan Tissue Expander	LPP15-R	FDA UDI	U	Active
Softspan Tissue Expander	SRE-CR-100	FDA UDI	U	Active
Silicone Gel Sizer	GSRBASE-700MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10621-590MP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10512-425MP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10712-425MP	FDA UDI	U	Active
Softspan Tissue Expander	SRE-LR-160	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10621-565HP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10610-110LPP	FDA UDI	U	Active
Silicone Gel Sizer	GSRBASE-190MP	FDA UDI	Class III	Active
SIENTRA Anatomical Controlled Tissue Expander (ACX)	20719-650ACX	FDA UDI	U	Unknown
SIENTRA Silicone Gel Breast Implant Sizer	GS10610-225LPP	FDA UDI	U	Active
Dermaspan Tissue Expander	LPP-FH12-RS	FDA UDI	U	Active
Softspan Tissue Expander	SRE-LR-160S	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10621-510XP	FDA UDI	U	Active
Dermaspan Tissue Expander	LPP11-RS	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10721-525MP	FDA UDI	U	Active
Silicone Gel Sizer	GSCBASE-350MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10621-800HP	FDA UDI	U	Active
Dermaspan Tissue Expander	LPP13S	FDA UDI	U	Active
SIENTRA Pectoral Implant	20132-160EU	FDA UDI	Class II	Unknown
Silicone Gel Sizer	GSRBASE-415MP	FDA UDI	Class III	Active
Silicone Gel Sizer	GSRBASE-320MP	FDA UDI	Class III	Active
Softspan Tissue Expander	SIE-CR-100S	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10610-300LPP	FDA UDI	U	Active
SIENTRA Gluteal Implant	20922-165U	FDA UDI	Class II	Unknown
Softspan Tissue Expander	SRE-RD-270S	FDA UDI	U	Active
Dermaspan Tissue Expander	LPP14-R	FDA UDI	U	Active
Sientra, inc. Portfinder	K221127	FDA 510(k)	U	Active
AlloX2 Pro Tissue Expanders	K214124	FDA 510(k)	U	Active

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