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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 6 of 30

Device	Model / Reference	Registries	Class	Status
SIENTRA Silicone Gel Breast Implant Sizer	GS10721-325MP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	10610-440LPP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20676-545HP	FDA UDI	Class III	Unknown
SIENTRA Silicone Gel Breast Implant	10621-255HP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	10721-305MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	10610-220LP	FDA UDI	Class III	Active
Softspan Tissue Expander	SRE-RD-430	FDA UDI	U	Active
Dermaspan Tissue Expander	LPP11	FDA UDI	U	Active
Softspan Tissue Expander	SRE-CV-520	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	20621-535HP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20645-335HP	FDA UDI	Class III	Active
AlloX2 Tissue Expander	AlloX2-15SE	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	20645-300HP	FDA UDI	Class III	Unknown
Silicone Gel Breast Implant	OBASE-700LP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20721-470HP	FDA UDI	Class III	Active
Silicone Gel Breast Implant	OBASE-500LP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10712-470MP	FDA UDI	U	Active
Softspan Tissue Expander	SIE-LR-127S	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	10610-425LP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20712-350MP	FDA UDI	Class III	Active
Silicone Gel Sizer	GSOBASE-440HP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20712-080MP	FDA UDI	Class III	Active
Softspan Tissue Expander	SHR-CV-720S	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	20676-600HP	FDA UDI	Class III	Unknown
AlloX2 Tissue Expander	AlloX2-FH11E	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	10710-100LP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20676-575MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20721-620HP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20721-385HP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	10710-080LPP	FDA UDI	Class III	Active
Silicone Gel Sizer	GSRBASE-300MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	10710-340LP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	10621-540MP	FDA UDI	Class III	Active
OPUS Silicone Gel Breast Implant	RBASE-320HP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20612-270MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10512-230MP	FDA UDI	U	Active
OPUS Silicone Gel Breast Implant	RBASE-170MP	FDA UDI	Class III	Active
SIENTRA Tissue Expander	820-150U3	FDA UDI	U	Unknown
SIENTRA Silicone Gel Breast Implant Sizer	GS10712-410MP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	10712-170MP	FDA UDI	Class III	Active
SIENTRA Anatomical Controlled Tissue Expander (ACX)	20769-500ACX	FDA UDI	U	Unknown
AlloX2 Tissue Expander	AlloX2-FH16SE	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10610-235LPP	FDA UDI	U	Active
Dermaspan Tissue Expander	LPP16-RS	FDA UDI	U	Active
OPUS Silicone Gel Breast Implant	RBASE-540MP	FDA UDI	Class III	Active
OPUS Silicone Gel Breast Implant	20621-510XP	FDA UDI	Class III	Active
SIENTRA Chin Implant	15-060U	FDA UDI	Class II	Unknown
SIENTRA Silicone Gel Breast Implant	10610-080LP	FDA UDI	Class III	Unknown
SIENTRA Silicone Gel Breast Implant Sizer	GS10610-335LPP	FDA UDI	U	Active
SIENTRA Anatomical Controlled Tissue Expander (ACX)	20719-535ACX	FDA UDI	U	Unknown

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