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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 17 of 30

Device	Model / Reference	Registries	Class	Status
SIENTRA Silicone Gel Breast Implant	20645-290MP	FDA UDI	Class III	Unknown
SIENTRA Silicone Gel Breast Implant	10621-415HP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	10512-380MP	FDA UDI	Class III	Active
SIENTRA Tissue Expander	20829-700GU	FDA UDI	U	Unknown
SIENTRA Silicone Gel Breast Implant	20645-150MP	FDA UDI	Class III	Unknown
SIENTRA Silicone Gel Breast Implant Sizer	GS10721-750MP	FDA UDI	U	Active
SIENTRA Tissue Expander	810-720U3	FDA UDI	U	Unknown
SIENTRA Tissue Expander	20829-300GU	FDA UDI	U	Unknown
SIENTRA Tissue Expander	800-600U3	FDA UDI	U	Unknown
OPUS Silicone Gel Breast Implant Sizer	GS10621-205HP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10610-310LP	FDA UDI	U	Active
Dermaspan Tissue Expander	LPP-FH14-RS	FDA UDI	U	Active
SIENTRA Chin Implant	10-035U	FDA UDI	Class II	Unknown
Dermaspan Tissue Expander	LPP12	FDA UDI	U	Active
SIENTRA Tissue Expander	800-1000U3	FDA UDI	U	Unknown
SIENTRA Silicone Gel Breast Implant	20621-240HP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10512-380MP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	10610-340LP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20712-470MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10610-080LPP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	20621-540MP	FDA UDI	Class III	Active
Silicone Gel Sizer	GSOBASE-210HP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	10621-485MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20621-280HP	FDA UDI	Class III	Active
Softspan Tissue Expander	SRE-WG-100	FDA UDI	U	Active
Dermaspan Tissue Expander	LPP-FH14	FDA UDI	U	Active
OPUS Silicone Gel Breast Implant	CBASE-575MP	FDA UDI	Class III	Active
OPUS Silicone Gel Breast Implant	RBASE-300MP	FDA UDI	Class III	Active
OPUS Silicone Gel Breast Implant	10712-550MP	FDA UDI	Class III	Active
OPUS Silicone Gel Breast Implant	20621-340XP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20612-300MP	FDA UDI	Class III	Active
Softspan Tissue Expander	SRE-FK-270S	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	20676-190HP	FDA UDI	Class III	Unknown
SIENTRA Silicone Gel Breast Implant	20645-400MP	FDA UDI	Class III	Unknown
Silicone Gel Sizer	GSCBASE-575MP	FDA UDI	Class III	Active
SIENTRA Anatomical Controlled Tissue Expander (ACX)	20799-780ACX	FDA UDI	U	Unknown
SIENTRA Silicone Gel Breast Implant Sizer	GS10712-270MP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10721-215MP	FDA UDI	U	Active
AlloX2 Tissue Expander	AlloX2-FH16E	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	10710-080LP	FDA UDI	Class III	Active
Softspan Tissue Expander	SPR500	FDA UDI	U	Active
SIENTRA Oval Carving Block Implant	3232-030U	FDA UDI	Class II	Unknown
SIENTRA Silicone Gel Breast Implant	10712-120MP	FDA UDI	Class III	Active
Softspan Tissue Expander	SRE-RD-750	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10512-320MP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	20645-270MP	FDA UDI	Class III	Active
Silicone Gel Sizer	GSCBASE-400MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10621-240HP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	20646-295HP	FDA UDI	Class III	Active
OPUS Silicone Gel Breast Implant	CBASE-460HP	FDA UDI	Class III	Active

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