Silicone Carving Implant

FDA UDI

Class II (US FDA UDI)

by Aart

Identity

Trade Name: Silicone Carving Implant FDA UDI
Generic Name: Silicone-block tissue reconstructive material FDA UDI
Device Name: Silicone Carving Implant Style 6 Size 4 with Suture Tabs FDA UDI
Model / Reference: D FDA UDI
Description: Silicone Carving Implant Style 6 Size 4 with Suture Tabs FDA UDI

Identifiers

Catalog Number: 600-604-9A FDA UDI
Primary DI / UDI-DI: B4906006049 FDA UDI
510(k) Number: K021820 FDA UDI
FDA Product Code: MIB FDA UDI
GMDN Term: Silicone-block tissue reconstructive material FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.3620 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Dry Heat Sterilization FDA UDI

Category: Silicone-block tissue reconstructive material

Silicone Carving Implant by Aart — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Silicone-block tissue reconstructive material.

SG Gluteal Implant — Implantech Associates, Inc. · Class II
Contoured Carving Block — Implantech Associates, Inc. · Class II
ContourFlex™ Calf Implant Sizer — Implantech Associates, Inc. · Class II
Spectrum Designs Medical — Spectrum Designs, Inc. · Class II
Powerflex™ Pectoral Implant — Implantech Associates, Inc. · Class II
SG Pec Sizer — Implantech Associates, Inc. · Class II
SG Pec Implant Style 4 — Implantech Associates, Inc. · Class II
Rectangular Carving Block 2.0 — Implantech Associates, Inc. · Class II

Cleared under the same submission

K021820 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Aart

Sources (1)

FDA UDI 9462674c-9ae7-471d-bd64-2edf446eef66 36 fields · synced May 30, 2026