Is this your brand? Sign in to claim ownership.

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 22 of 30

Device	Model / Reference	Registries	Class	Status
Dermaspan Tissue Expander	LPP-FH11	FDA UDI	U	Active
Silicone Gel Breast Implant	OBASE-410LP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20645-475MP	FDA UDI	Class III	Active
Softspan Tissue Expander	SIE-LR-064S	FDA UDI	U	Active
Silicone Gel Sizer	GSCBASE-335MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10621-225HP	FDA UDI	U	Active
Winged Needle Infusion Set	WNIS01	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10512-190MP	FDA UDI	U	Active
OPUS Silicone Gel Breast Implant	RBASE-270HP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10721-315XP	FDA UDI	U	Active
OPUS Silicone Gel Breast Implant	CBASE-285HP	FDA UDI	Class III	Active
Silicone Gel Breast Implant	OBASE-525MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20612-410MP	FDA UDI	Class III	Active
Silicone Gel Breast Implant	OBASE-180HP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20646-275MP	FDA UDI	Class III	Unknown
SIENTRA Tissue Expander	810-320U3	FDA UDI	U	Unknown
Softspan Tissue Expander	SHR-EL-010S	FDA UDI	U	Active
OPUS Silicone Gel Breast Implant	10721-510XP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	10710-210LPP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10721-330HP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10610-255LPP	FDA UDI	U	Active
OPUS Silicone Gel Breast Implant	10712-285MP	FDA UDI	Class III	Active
SIENTRA Anatomical Controlled Tissue Expander (ACX)	20789-390ACX	FDA UDI	U	Unknown
SIENTRA Malar Implant	25-45DU	FDA UDI	Class II	Unknown
SIENTRA Silicone Gel Breast Implant	10610-160LP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10512-350MP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10621-625MP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	10512-210MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10512-120MP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10721-385MP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	20645-440HP	FDA UDI	Class III	Active
Silicone Gel Sizer	GSCBASE-210MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20721-435MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10712-650MP	FDA UDI	U	Active
Softspan Tissue Expander	SRE-RD-500	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	10721-435MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	10621-155MP	FDA UDI	Class III	Unknown
SIENTRA Silicone Gel Breast Implant Sizer	GS10721-485MP	FDA UDI	U	Active
SIENTRA Pectoral Implant	20132-150DU	FDA UDI	Class II	Unknown
SIENTRA Silicone Gel Breast Implant	10721-190HP	FDA UDI	Class III	Active
OPUS Silicone Gel Breast Implant	CBASE-600MP	FDA UDI	Class III	Active
OPUS Silicone Gel Breast Implant Sizer	GS10621-435MP	FDA UDI	U	Active
OPUS Silicone Gel Breast Implant	CBASE-365HP	FDA UDI	Class III	Active
AlloX2 Tissue Expander	AlloX2-FH15E	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	20676-635HP	FDA UDI	Class III	Unknown
SIENTRA Silicone Gel Breast Implant Sizer	GS10712-600MP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	20721-505MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant	20712-700MP	FDA UDI	Class III	Active
SIENTRA Silicone Gel Breast Implant Sizer	GS10621-195MP	FDA UDI	U	Active
SIENTRA Silicone Gel Breast Implant	20676-335MP	FDA UDI	Class III	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.