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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 9 of 30

Device	Model / Reference	Registries	Class	Status
SIENTRA Anatomical Controlled Tissue Expander (ACX)	20789-840ACX	FDA UDI	U	Unknown
SIENTRA Nostril Retainer	1171-018U	FDA UDI	Class I	Unknown
SIENTRA Chin Implant	10-050U	FDA UDI	Class II	Unknown
SIENTRA Silicone Gel Breast Implant	10610-390LPP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10712-800MP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	20712-300MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	10710-225LPP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	10610-300LPP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	10721-700HP	FDA UDI	Class III	Active
SIENTRA Oval Carving Block Implant	3232-025U	FDA UDI	Class II	Unknown
SIENTRA Silicone Gel Breast Implant Sizer	GS10721-565HP	FDA UDI	U	Active
OPUS Silicone Gel Breast Implant	20721-360XP	FDA UDI	Class III	Active
OPUS Silicone Gel Breast Implant	CBASE-310MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20645-575MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20645-625MP	FDA UDI	Class III	Active
OPUS Silicone Gel Breast Implant Sizer	GS10621-255HP	FDA UDI	U	Active
Silicone Gel Breast Implant	OBASE-370MP	FDA UDI	Class III	Active
Silicone Gel Sizer	GSRBASE-170MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10621-135MP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	20645-600HP	FDA UDI	Class III	Active
Silicone Gel Breast Implant	OBASE-290MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10721-505HP	FDA UDI	U	Active
Silicone Gel Breast Implant	OBASE-150MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10621-650MP	FDA UDI	U	Active
Softspan Tissue Expander	SRE-LR-340	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10621-395XP	FDA UDI	U	Active
Silicone Gel Breast Implant	OBASE-240HP	FDA UDI	Class III	Active
Dermaspan Tissue Expander	LPP-FH16	FDA UDI	U	Active
OPUS Silicone Gel Breast Implant	RBASE-245MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20646-500MP	FDA UDI	Class III	Unknown
SIENTRA Tissue Expander	819-160U	FDA UDI	U	Unknown
SIENTRA Silicone Gel Breast Implant	20610-190LP	FDA UDI	Class III	Active
AlloX2 Tissue Expander	AlloX2-15E	FDA UDI	U	Active
SIENTRA Nasal Implant	71-060U	FDA UDI	Class II	Unknown
Silicone Gel Sizer	GSRBASE-260MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20610-250LP	FDA UDI	Class III	Active
Dermaspan Tissue Expander	LPP12-R	FDA UDI	U	Active
Softspan Tissue Expander	SHR-CV-750S	FDA UDI	U	Active
Softspan Tissue Expander	SHR-LR-100S	FDA UDI	U	Active
OPUS Silicone Gel Breast Implant	RBASE-370HP	FDA UDI	Class III	Active
SIENTRA Anatomical Controlled Tissue Expander (ACX)	20769-700ACX	FDA UDI	U	Unknown
SIENTRA Silicone Gel Breast Implant	10621-565HP	FDA UDI	Class III	Active
SIENTRA Anatomical Controlled Tissue Expander (ACX)	20719-830ACX	FDA UDI	U	Unknown
Softspan Tissue Expander	SRE-WG-100S	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10621-245XP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10610-175LPP	FDA UDI	U	Active
Softspan Tissue Expander	BTE1000	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10610-160LP	FDA UDI	U	Active
Silicone Gel Sizer	GSOBASE-210MP	FDA UDI	Class III	Active
Softspan Tissue Expander	SRE-FK-080S	FDA UDI	U	Active

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