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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 29 of 30

Device	Model / Reference	Registries	Class	Status
SIENTRA Silicone Gel Breast Implant	10710-700LP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20712-230MP	FDA UDI	Class III	Active
SIENTRA Calf Implant	402-100U	FDA UDI	Class II	Unknown
Dermaspan Tissue Expander	LPP13-RS	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10721-575MP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10721-195MP	FDA UDI	U	Active
OPUS Silicone Gel Breast Implant	CBASE-210MP	FDA UDI	Class III	Active
Dermaspan Tissue Expander	LPP15-RS	FDA UDI	U	Active
OPUS Silicone Gel Breast Implant	10712-250MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10721-440HP	FDA UDI	U	Active
OPUS Silicone Gel Breast Implant	10721-395XP	FDA UDI	Class III	Active
Softspan Tissue Expander	SPR1000	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10721-350HP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	20710-100LP	FDA UDI	Class III	Active
Silicone Gel Sizer	GSCBASE-250HP	FDA UDI	Class III	Active
Softspan Tissue Expander	SRE-FK-270	FDA UDI	U	Active
Dermaspan Tissue Expander	LPP-FH15S	FDA UDI	U	Active
OPUS Silicone Gel Breast Implant	CBASE-650MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20646-270RB	FDA UDI	Class III	Unknown
SIENTRA Silicone Gel Breast Implant	20721-305MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20621-235MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20710-550LP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	10610-650LP	FDA UDI	Class III	Active
Silicone Gel Sizer	GSCBASE-310MP	FDA UDI	Class III	Active
Softspan Tissue Expander	SRE-RD-320	FDA UDI	U	Active
OPUS Silicone Gel Breast Implant	RBASE-160MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20721-225HP	FDA UDI	Class III	Active
SIENTRA Anatomical Controlled Tissue Expander (ACX)	20789-320ACX	FDA UDI	U	Unknown
Softspan Tissue Expander	SIE-CR-045S	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10512-600MP	FDA UDI	U	Active
Silicone Gel Sizer	GSCBASE-375MP	FDA UDI	Class III	Active
OPUS Silicone Gel Breast Implant Sizer	GS10621-535HP	FDA UDI	U	Active
Dermaspan Tissue Expander	LPP12-RS	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10721-700HP	FDA UDI	U	Active
SIENTRA Oval Carving Block Implant	3232-050U	FDA UDI	Class II	Unknown
SIENTRA Silicone Gel Breast Implant Sizer	GS10621-650HP	FDA UDI	U	Active
Silicone Gel Sizer	GSCBASE-475MP	FDA UDI	Class III	Active
Silicone Gel Sizer	GSCBASE-625MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10610-320LPP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10721-205HP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10712-285MP	FDA UDI	U	Active
Softspan Tissue Expander	BTE500	FDA UDI	U	Active
Softspan Tissue Expander	SHR-LR-110S	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10512-365MP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10621-340XP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10721-275XP	FDA UDI	U	Active
Silicone Gel Sizer	GSCBASE-425MP	FDA UDI	Class III	Active
SIENTRA Anatomical Controlled Tissue Expander (ACX)	20719-250ACX	FDA UDI	U	Unknown
SIENTRA Silicone Gel Breast Implant Sizer	GS10512-080MP	FDA UDI	U	Active
Dermaspan Tissue Expander	LPP-FH11S	FDA UDI	U	Active

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