FDA.report

900-012 Extended Malar Sizer Set

Primary DI
M7249000121
Brand
900-012 Extended Malar Sizer Set
Company
IMPLANTECH ASSOCIATES, INC.
Model
900-012
Catalog number
900-012
Device description
Malar Sizer Set
Published
2021-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LZKImplant, Malar

Product Code Classifications

CodeDeviceSpecialtyClass
LZKImplant, MalarGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
M7249000121PrimaryHIBCC0

GMDN Terms

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.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1-800-733-0833info@implantech.com

Regulatory Flags

DUNS number
784664955
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
M724SMCOBL20FF1Silicone BlockSMCO-BL-2.0-FFSMCO-BL-2.0-FF2026-01-28
M724SMCOBL20OF1Silicone BlockSMCO-BL-2.0-OFSMCO-BL-2.0-OF2026-01-28
M724SMCOBL20OVS1Silicone BlockSMCO-BL-2.0-OVSSMCO-BL-2.0-OVS2026-01-28
M724SMCOBL20WF1Silicone BlockSMCO-BL-2.0-WFSMCO-BL-2.0-WF2026-01-28
M724SMCOBL20WVS1Silicone BlockSMCO-BL-2.0-WVSSMCO-BL-2.0-WVS2026-01-28
M724NGBL20CVFNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-CVF-NS2025-08-27
M724NGBL20FFEZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-FF-EZ-NS2025-08-27
M724NGBL20FMEZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-FM-EZ-NS2025-08-27
M724NGBL20FSNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-FS-NS2025-08-27
M724NGBL20OVSNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-OVS-NS2025-08-27
M724NGBL20RFM30EZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-RFM30-EZ-NS2025-08-27
M724NGBL20RFS15EZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-RFS15-EZ-NS2025-08-27
M724NGBL20RFS20EZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-RFS20-EZ-NS2025-08-27
M724NGBL20RFSEZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-RFS-EZ-NS2025-08-27
M724NGBL20RFVS5NS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-RFVS5-NS2025-08-27
M724NGBL20RFXSNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-RFXS-NS2025-08-27
M724NGBL20WF44EZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-WF44-EZ-NS2025-08-27
M724ESL58501Solid ePTFE Nasal L Implantsize:5850ES-L58502024-11-01
M724ESL62601Solid ePTFE Nasal L Implantsize:6260ES-L62602024-11-01
M724ESPF501Solid ePTFE Paranasal, Flat Topsize:5mmES-PF-502024-11-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
B4904011015Malar ImplantAartLZK2025-08-28
B4904011016Malar ImplantAartLZK2025-08-28
B4904011025Malar ImplantAartLZK2025-08-28
B4904011026Malar ImplantAartLZK2025-08-28
B4904011035Malar ImplantAartLZK2025-08-28
B4904011036Malar ImplantAartLZK2025-08-28
B4904012015Malar ImplantAartLZK2025-08-28
B4904012016Malar ImplantAartLZK2025-08-28
B4904012025Malar ImplantAartLZK2025-08-28
B4904012026Malar ImplantAartLZK2025-08-28
M724ESPF501Solid ePTFE Paranasal, Flat TopIMPLANTECH ASSOCIATES, INC.LZK2024-11-01
M724ESPF701Solid ePTFE Paranasal, Flat TopIMPLANTECH ASSOCIATES, INC.LZK2024-11-01
M724ESPS501Solid ePTFE Paranasal, Sharp TopIMPLANTECH ASSOCIATES, INC.LZK2024-11-01
00888233043717HTR-PMIBIOMET MICROFIXATION, INCLZK2021-07-28
00888233043786HTR-PMIBIOMET MICROFIXATION, INCLZK2021-07-28
00888233043793HTR-PMIBIOMET MICROFIXATION, INCLZK2021-07-28
00888233044271HTR-PMIBIOMET MICROFIXATION, INCLZK2021-07-28
00888233044288HTR-PMIBIOMET MICROFIXATION, INCLZK2021-07-28
00888233044295HTR-PMIBIOMET MICROFIXATION, INCLZK2021-07-28
M7249000101900-010 Anatomical Malar I Sizer SetIMPLANTECH ASSOCIATES, INC.LZK2021-07-20
M7249000111900-011 Anatomical Malar II Sizer SetIMPLANTECH ASSOCIATES, INC.LZK2021-07-20
M7249000131900-013 Combined Malar Sizer SetIMPLANTECH ASSOCIATES, INC.LZK2021-07-20
M724120214S1Anatomical Malar IIMPLANTECH ASSOCIATES, INC.LZK2021-04-13
M724120224S1Anatomical Malar IIMPLANTECH ASSOCIATES, INC.LZK2021-04-13
M724120234S1Anatomical Malar IIMPLANTECH ASSOCIATES, INC.LZK2021-04-13
M724130314S1Anatomical Malar IIIMPLANTECH ASSOCIATES, INC.LZK2021-04-13
M724130324S1Anatomical Malar IIIMPLANTECH ASSOCIATES, INC.LZK2021-04-13
M724130334S1Anatomical Malar IIIMPLANTECH ASSOCIATES, INC.LZK2021-04-13
M724140414S1Profile MalarIMPLANTECH ASSOCIATES, INC.LZK2021-04-13
M724140424S1Profile MalarIMPLANTECH ASSOCIATES, INC.LZK2021-04-13