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IDEAL IMPLANTIDEAL IMPLANT Structured Breast Implants (Puregraft Serene)

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IDEAL IMPLANT is a Breast implant product (Class III device), registered by Bimini Health Tech. Linked registrations: US P120011. First approved in US on 2014-11-14 (P120011). Data as of 2026-11-09.

  • Regulatory classBreast implant · Class III device
  • HolderBimini Health Tech
  • JurisdictionsUS
  • Updated2026-11-09 · v1

Registration and basics are public; findings and prices need an account

Registration and basics

IDEAL IMPLANT

Product
Regulatory class
Class III device
Category
Breast implant
US · FDA PMA
P120011
Name on registration
Puregraft Serene Breast Implant
Registrant
Bimini Health Tech
First approval
2014-11-14
Checked against official page
Not yet checked field by field against the live official page

Public: fields from the registration record.

Label facts by jurisdiction

What each jurisdiction's label says for the same attribute; gaps are marked Not reported, irrelevant ones N/A

No data yet

Registration timeline

  1. US

    P120011 first approved

  2. US

    P120011 · P120011/S024

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Trelleborg Sealing Solutions US, Inc. to resume fabrication of sili…

  3. US

    P120011 · P120011/S023

    Normal 180 Day Track No User Fee｜Location Change - Manufacturer/Sterilizer/Packager/Supplier｜Approval for a new manufacturing site at Bentec…

  4. US

    P120011 · P120011/S027

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Transferring of certain QC tests to the manufacturing site.

  5. US

    P120011 · P120011/S026

    Normal 180 Day Track No User Fee｜Labeling Change - Indications/instructions/shelf life/tradename｜Approval for changing the name from IDEAL I…

  6. US

    P120011 · P120011/S025

    Normal 180 Day Track No User Fee｜Labeling Change - PAS｜Approval for updated Instructions for Use and Patient Information Booklet

  7. US

    P120011 · P120011/S028

    Normal 180 Day Track No User Fee｜Labeling Change - PAS｜Approval to update the Instructions for Use and the Patient Information Booklet that …

First approval, this certificate's issue date (updated after renewals or changes), changes and expiry are listed separately; a missing first approval means it was not obtained from an official source. Up to 6 recent changes per registration; click the number for the full record. Dates on non-Chinese registrations keep the source's wording: UK devices show the registration date (MHRA does not approve them), Australia the ARTG start date, FDA devices the decision date.

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Recent changes

5
  • P120011: Normal 180 Day Track No User Fee｜Labeling Change - PAS｜Approval to update the In…2025-02-11
  • P120011: Normal 180 Day Track No User Fee｜Labeling Change - PAS｜Approval for updated Inst…2024-08-16
  • P120011: Normal 180 Day Track No User Fee｜Labeling Change - Indications/instructions/shel…2024-03-15
  • P120011: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Transfe…2023-11-18
  • P120011: Normal 180 Day Track No User Fee｜Location Change - Manufacturer/Sterilizer/Packa…2023-02-01

Sources

1