FDA.reportPublic FDA data

Composite™ ePTFE-Coated Auricular Posterior Block

Primary DI
M724EPTFEAPB63R1
Brand
Composite™ ePTFE-Coated Auricular Posterior Block
Company
IMPLANTECH ASSOCIATES, INC.
Model
Size 63, Right
Catalog number
EPTFE-APB-63R
Device description
Auricular Implant
Published
2023-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZDProsthesis, Ear, Internal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZDProsthesis, Ear, InternalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172389000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172389000ePTFE-Coated Auricular ImplantImplantech Associates, Inc.2018-07-18FZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M724EPTFEAPB63R1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
External ear prosthesis, implantableA device intended to be fully- or partially- implanted to reconstruct the external ear by replacing damaged or missing tissue. It is typically made of a polymer material (e.g., solid silicone rubber).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-733-0833info@implantech.com

Regulatory Flags#

DUNS number
784664955
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M724MCTBL10GF11Silicone Block, Grey, Firm 50 (EZ)Size: 14.5cm x 7.7cm x 1.0 cmMCT-BL-1.0-GF12026-04-16
M724MCTBL10GF21Silicone Block, Grey, Firm 50 (EZ)Size: 13.6cm x 5.8cm x 1.0cmMCT-BL-1.0-GF22026-04-16
M724MCTBL10OF1Silicone Block, Opaque, Firm 40 (EZ)Size: 13.6cm x 5.8cm x 1.0cmMCT-BL-1.0-OF2026-04-16
M724MCTBL13GM1Silicone Block, Grey, Medium 35 (EZ)Size: 15.0cm x 7.6cm x 1.3cmMCT-BL-1.3-GM2026-04-16
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
M724SLV6341Gelzone® Shoulder SleeveSLV634SLV6342023-06-22
M724NGBL20WMEZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-WM-EZ-NS2025-08-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M724EPTFEAAH55L1Composite™ ePTFE- Coated Auricular Anti-HelixIMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEAAH55R1Composite™ ePTFE-Coated Auricular Anti-Helix IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEAAH58L1Composite™ ePTFE-Coated Auricular Anti-Helix IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEAAH58R1Composite™ ePTFE-Coated Auricular Anti-Helix IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEAAH61L1Composite™ ePTFE-Coated Auricular Anti-Helix IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEAAH61R1Composite™ ePTFE-Coated Auricular Anti-Helix IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEAAH63L1Composite™ ePTFE-Coated Auricular Anti-Helix IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEAAH63R1Composite™ ePTFE-Coated Auricular Anti-Helix IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEABF55L1Composite™ ePTFE-Coated Auricular Base Frame IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEABF55R1Composite™ ePTFE-Coated Auricular Base Frame IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEABF58L1Composite™ ePTFE-Coated Auricular Base Frame IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEABF58R1Composite™ ePTFE-Coated Auricular Base FrameIMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEABF61L1Composite™ ePTFE-Coated Auricular Base Frame IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEABF61R1Composite™ ePTFE-Coated Auricular Base FrameIMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEABF63L1Composite™ ePTFE-Coated Auricular Base FrameIMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEABF63R1Composite™ ePTFE-Coated Auricular Base Frame IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEAPB55L1Composite™ ePTFE-Coated Auricular Posterior Block IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEAPB55R1Composite™ ePTFE-Coated Auricular Posterior BlockIMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEAPB58L1Composite™ ePTFE-Coated Auricular Posterior BlockIMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEAPB58R1Composite™ ePTFE-Coated Auricular Posterior Block IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEAPB61L1Composite™ ePTFE-Coated Auricular Posterior Block IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEAPB61R1Composite™ ePTFE-Coated Auricular Posterior Block IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEAPB63L1Composite™ ePTFE-Coated Auricular Posterior BlockIMPLANTECH ASSOCIATES, INC.FZD2023-07-06
00821925015531GYRUS ACMI, INCGyrus ACMI, LLCFZD2015-10-24
00821925015548GYRUS ACMI, INCGyrus ACMI, LLCFZD2015-10-24
00821925015555GYRUS ACMI, INCGyrus ACMI, LLCFZD2015-10-24