Device Desk

Private service · Not FDA

FDA device establishment · Birmingham, AL

This page shows the yearly renewal for this site, from FDA’s public record.

Device Desk is a private service. We are not FDA. We never file or pay for you.

Renewal dossierDD-1060818As of September 30, 2026

BIOHORIZONS IMPLANT SYSTEMS INC.

Registration 1060818FEI 1000592496BIRMINGHAM, AL

Owner/operator: BIOHORIZONS IMPLANT SYSTEMS, INC.

  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Device in the United States for Export Only
  • Manufacture Medical Device

Renewal due by December 31, 2026

Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.

90days left in the window

The 2026 window

  1. Oct 1Window opens91 days left
  2. Nov 3Where you stand58 days left
  3. Dec 1Our pay-by date30 days left
  4. Dec 15Two weeks left16 days left
  5. Dec 23Holiday week8 days left
  6. Dec 29Two days left2 days left
  7. Dec 31Window closes0 days left
an email on that date our pay-by date to December 31
FDA fee, FY2027
$13,785
Our pay-by suggestion
Dec 1
Listed devices
54
Added, last 12 months
5

FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page

The steps, in order

  1. Pay FDA's annual feeYou

    Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.

    FDA: registration and listing payment process

  2. Wait for the payment confirmation numberYou

    FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.

    FDA: registration and listing payment process

  3. Renew the registration in FDA's systemYou

    Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.

    FDA: device registration and listing

  4. Review every listingYou

    In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.

    FDA: device registration and listing

Every listed device 54

CodeDeviceClassRegulationPremarket
NHAMini Drive-Lock Dental Implant System ProstheticsAbutment, Implant, Dental, EndosseousClass 221 CFR 872.3630K080598
NHABioHorizons Tapered Internal Implant SystemAbutment, Implant, Dental, EndosseousClass 221 CFR 872.3630K071638
NHABioHorizons Abutments for ZimmerAbutment, Implant, Dental, EndosseousClass 221 CFR 872.3630K103691
NHAIntra-Lock Endosseous ImplantsAbutment, Implant, Dental, EndosseousClass 221 CFR 872.3630K021322
NHACAD/CAM BarsAbutment, Implant, Dental, EndosseousClass 221 CFR 872.3630K180998
NHABioHorizons Laser-Lok 3 Implant SystemAbutment, Implant, Dental, EndosseousClass 221 CFR 872.3630K093321
NHASmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank AbutmentAbutment, Implant, Dental, EndosseousClass 221 CFR 872.3630K240531
NHATapered Pro Conical Implant SystemAbutment, Implant, Dental, EndosseousClass 221 CFR 872.3630K240187
NHAMilo Dental Implant SystemAbutment, Implant, Dental, EndosseousClass 221 CFR 872.3630K050970
NHAMaestro SystemAbutment, Implant, Dental, EndosseousClass 221 CFR 872.3630K022795
NHAMRI compatibility for existing BioHorizons dental implants and abutmentsAbutment, Implant, Dental, EndosseousClass 221 CFR 872.3630K223697
NHAMulti-unit Abutments for CONELOGAbutment, Implant, Dental, EndosseousClass 221 CFR 872.3630K203252

and 42 more on your full dossier

What changed

  • Jun 30, 2026Listing added: NHA — CEREC Compatible Ti-Bases (K260061)
  • Jun 30, 2026Listing added: PNP — CEREC Compatible Ti-Bases (K260061)
  • Nov 25, 2025Listing added: DZE — ACE SURIGICAL TRU-FIX IMPLANT SYSTEM (K080074)
  • Nov 25, 2025Listing added: JEY — MINIBONEPLATE SYSTEM (K951392)
  • Nov 25, 2025Listing added: DZL — ACE BONE SCREW TACKING KIT (K951510)
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov). FDA does not endorse Device Desk.FDA’s own record is always the authority.

How we got this date

  1. FDA asks every device site to renew its registration each year.
  2. The renewal window runs from October 1, 2026 to December 31, 2026.
  3. A renewal in this window covers 2027.
  4. The rule is 21 CFR 807.22(b).

FDA’s record shows this registration runs through 2026.

We read this from FDA’s public record on September 30, 2026.

Read FDA’s page on registration

Watch for mail that looks like it is from FDA and asks you to pay a company. You pay FDA’s fee only in FDA’s own system.

Keep this desk: $249 a year

We keep this page current each week. We email you before each date in the window, and when FDA’s record shows you renewed.

Already a member? Sign in

Renews each year until you cancel. Cancel any time from your account.

Is this right?

We copy this from FDA’s public record. FDA’s own record always wins. A listing missing here does not prove anything about FDA’s record.

More device sites in Alabama