Contact:haixiao@sungolytest.com+86 158 2169 5110 (WeChat)+86 132 4819 8029 Members 中文
Home›USA›BioHorizons Implant Systems, Inc.

BioHorizons Implant Systems, Inc.

USA · Birmingham
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
8listed device types
Class I 2Class II 6Class III 0
plus 45 registration records and 41 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
11registered devices
Class I 7Class II 4
16 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
4active device licences
Class II 2Class III 2
28 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States45 registration records, 41 510(k), 0 PMA
Brazil11 confirmed, 0 excluded
Canada4 confirmed, 0 excluded
Manufacturer names merged into this page: BIOHORIZONS IMPLANT SYSTEMS INC. · BIOHORIZONS IMPLANT SYSTEM INC.
Same-named companies — This database also contains companies with near-identical names: BIOHORIZONS IMPLANT SYSTEM INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Birmingham

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

22001
42002
22003
22004
22005
22006
12007
32008
22010
22011
12012
12015
12016
12017
22018
12021
12023
22024
12025
12026

FDA listed device types

Plate, Bone 1Screw, Fixation, Intraosseous 1Dental Abutment Design Software For Dental Laboratory 1Abutment, Implant, Dental, Endosseous 1Platelet And Plasma Separator For Bone Graft Handling 1Implant, Endosseous, Root-Form 1Crown, Preformed 1Accessories, Implant, Dental, Endosseous 1

Registration details (sample)

MarketIdentifierNameClass / date
USK260061BioHorizons CEREC Compatible Ti-Bases2026-06-26
USK243521Conical Ti Base abutments2025-05-01
USK240531SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment2024-07-30
BR80108910121BioHorizons Stainless Steel InstrumentsClass I
BR80108910122BioHorizons Tittanium InstrumentsClass I
BR80108910123BIOHORIZONS TAPERED PRO DRILLSClass I
CA4528BONESAVER AUTOGENOUS TISSUE COLLECTORClass II
CA81436MILO DENTAL IMPLANT SYSTEMClass III
CA87450INTRA-LOCK DENTAL IMPLANT SYSTEMClass III

Similar companies

Abaxis
USA · markets 9
Accorto Regulatory Solutions LLC
USA · markets 0
Accumold LLC
USA · markets 1
AccuVein Inc.
USA · markets 8
Acme Monaco Corporation
USA · markets 4
ACON Laboratories, Inc.
USA · markets 9
Is this your company? Claim the page, add information or report a data error.Claim / report an error →