FDA.reportPublic FDA data

SIENTRA Malar Implant

Primary DI
00812790023295
Brand
SIENTRA Malar Implant
Company
Sientra, Inc.
Model
25-40DU
Catalog number
25-40DU
Device description
Malar Implant, Solid Silicone, Anatomical, Smooth, Right, 40 mm
Published
2015-10-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZKImplant, Malar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZKImplant, MalarGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981835000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981835000SILIMED MALAR IMPLANTSilimed, LLC1998-07-09LZK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812790023295PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812790023295008127900232958127900232950812790023295

GMDN Terms#

Term, Definition table
TermDefinition
Malar prosthesisAn implantable device designed to augment or maintain the soft-tissue anatomy of the malar area (cheek). The device is typically a solid elastomer (e.g., silicone) available in several shapes and sizes for subdermal implantation in the malar area for cosmetic or reconstructive purposes following traumatic or disease/congenital deformation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length40Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-708-0808customer.experience@sientra.com

Regulatory Flags#

DUNS number
010209877
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810076894621Sientra Viality-1400Viality-1400Viality-14002023-03-13
00812790023196SIENTRA Nasal Implant71-060U71-060U2015-10-23
00812790023202SIENTRA Nasal Implant72-060U72-060U2015-10-23
00812790028191AlloX2 Tissue ExpanderAlloX2-FH11SEAlloX2-FH11SE2020-05-19
00812790028207AlloX2 Tissue ExpanderAlloX2-FH12SEAlloX2-FH12SE2020-05-19
00812790028214AlloX2 Tissue ExpanderAlloX2-FH13SEAlloX2-FH13SE2020-05-19
00812790028221AlloX2 Tissue ExpanderAlloX2-FH14SEAlloX2-FH14SE2020-05-19
00812790028238AlloX2 Tissue ExpanderAlloX2-FH15SEAlloX2-FH15SE2020-05-19
00812790028245AlloX2 Tissue ExpanderAlloX2-FH16SEAlloX2-FH16SE2020-05-19
00812790028252AlloX2 Tissue ExpanderAlloX2-FH11EAlloX2-FH11E2020-05-19
00812790028269AlloX2 Tissue ExpanderAlloX2-FH12EAlloX2-FH12E2020-05-19
00812790028276AlloX2 Tissue ExpanderAlloX2-FH13EAlloX2-FH13E2020-05-19
00812790028283AlloX2 Tissue ExpanderAlloX2-FH14EAlloX2-FH14E2020-05-19
00812790028290AlloX2 Tissue ExpanderAlloX2-FH15EAlloX2-FH15E2020-05-19
00812790028306AlloX2 Tissue ExpanderAlloX2-FH16EAlloX2-FH16E2020-05-19
00812790028313AlloX2 Tissue ExpanderAlloX2-12SEAlloX2-12SE2020-05-19
00812790028320AlloX2 Tissue ExpanderAlloX2-13SEAlloX2-13SE2020-05-19
00812790028337AlloX2 Tissue ExpanderAlloX2-14SEAlloX2-14SE2020-05-19
00812790028344AlloX2 Tissue ExpanderAlloX2-15SEAlloX2-15SE2020-05-19
00812790028351AlloX2 Tissue ExpanderAlloX2-16SEAlloX2-16SE2020-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M724BSMIISIZNS1Binder Submalar® II SizerIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724BSMSIZNS1Binder Submalar® SizerIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724CBSMSIZNS1Conform Binder Submalar® SizersIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724CCSMSIZNS1Conform Midfacial Implant SizersIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724CMASIZNS1Conform Mandibular Angle™ SizersIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724CSMSIZNS1Combined Submalar Shell™ SizersIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724CTMSSIZNS1Conform Terino Malar Shell® IMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724FTTSIZNS1Flowers Tear Trough® SizersIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724TMSSIZNS1Terino Malar Shell® SizersIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
00841036204181HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-15
00841036204198HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-15
00841036204204HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-15
00841036204211HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-15
00841036204228HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-15
00841036204235HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-15
00841036204242HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-15
00841036204259HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-15
00841036204273HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-15
00841036204280HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-15
00841036203955HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-14
00841036203979HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-14
00841036203856HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-09
00841036203788HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-08
00841036203795HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-08
00841036203801HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-08
00841036203580HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-07
00841036203610HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-07
00841036203627HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-07
00841036203351HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-04
00841036203368HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-04