Manufacturer Intelligence · Based on 18,531 FDA 510(k) records · 70 countries

FDA 510(k) Dental Device Manufacturers

Medical device manufacturers active in the FDA Dental review panel, ranked by 510(k) submission volume. Real data from the 510k Database dataset.

  • Compare manufacturers by FDA 510(k) submission activity
  • Identify clearance rates, active panels and years of FDA activity
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634
Manufacturers
Dental
Panel

Dental Manufacturers

1–50 of 634
# Manufacturer Submissions Cleared Active panels Country
1
Dentsply Sirona
York
33 100%
DE GU HO +1
US
2
BTL Industries, Inc.
Malborough
27 100%
DE GU NE +2
US
3
Prismatik Dentalcraft, Inc.
Newport Beach
27 100%
DE HO
US
4
Institut Straumann AG
Basel
26 100%
DE
CH
5
Dentis Co., Ltd.
Dalseo-Gu
24 100%
DE
KR
6
Stryker
Portage
24 100%
DE NE OR +1
US
7
Dentsply Sirona, Inc.
York
19 100%
DE HO RA
US
8
KLS-Martin L.P.
Jacksonville
19 100%
DE NE OR
US
9
Jeil Medical Corporation
Deer Field
19 100%
DE OR
US
10
Terrats Medical SL
Montcada I Reixac
19 100%
DE
ES
11
Materialise NV
Leuven
18 100%
DE NE OR +1
BE
12
Megagen Implant Co., Ltd.
Santa Fe Springs
18 100%
DE RA
US
13
Voco GmbH
Denver
17 100%
DE
US
14
Arum Dentistry Co., Ltd.
Yuseong-Gu, Daejeon
17 100%
DE
KR
15
DiaDent Group International
Chungcheong Buk-Do
16 100%
DE
KR
16
Aidite (Qinhuangdao) Technology Co., Ltd.
Qinhuangdao
16 100%
DE
CN
17
Stryker Leibinger GmbH & Co KG
Freiburg Im Breisgau
15 100%
DE NE OR +1
DE
18
Osteonic Co., Ltd.
Seoul
15 100%
DE NE OR
KR
19
Nakanishi, Inc.
Kanuma
15 100%
DE NE
JP
20
Geistlich Pharma AG
Washington
15 100%
DE OR SU
US
21
S.I.N. ? Sistema DE Implante Nacional S.A.
Sao Paulo
15 100%
DE HO
BR
22
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Curitiba
14 100%
DE HO
BR
23
Osstem Implant Co., Ltd.
Busan
13 100%
DE RA
KR
24
Neocis, Inc.
Miami
13 100%
DE
US
25
Rizhao Huge Biomaterials Company, Ltd.
Rizhao City
13 100%
DE
CN
26
Nobel Biocare AB
Goteborg
12 100%
DE RA
SE
27
Mediclus Co., Ltd.
Cheongju-Si
12 100%
DE
KR
28
Truabutment, Inc.
Anaheim
12 100%
DE
US
29
OsteoCentric Technologies
Logan
11 100%
DE OR
US
30
Collagen Matrix, Inc.
Franklin Lakes
10 100%
DE NE OR +1
US
31
Guilin Woodpecker Medical Instrument Co., Ltd.
Flintville
10 100%
DE RA
US
32
Synthes USA Products, LLC
West Chester
10 100%
DE NE OR
US
33
Rayence Co., Ltd.
Houston
10 100%
DE RA
US
34
Ray Co., Ltd.
Beverly Hills
10 100%
DE HO RA
US
35
Innobiosurg Co., Ltd.
Echo
10 100%
DE
US
36
Belport Company, Inc., Gingi-Pak
Camarillo
10 100%
DE
US
37
JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A.
Curitiba
10 100%
DE HO
BR
38
El.En Electronic Engineering Spa
Calenzano
9 100%
DE PM SU
IT
39
Genoss Co., Ltd.
Laguna Niguel
9 100%
DE
US
40
Shofu Dental Corporation
San Marcos
9 100%
DE
US
41
Implant Direct Sybron Manufacturing, LLC
Calabasas
9 100%
DE HO
US
42
Southern Implants (Pty), Ltd.
Irene
9 100%
DE HO
ZA
43
Sprintray, Inc.
Los Angeles
9 100%
DE
US
44
Cefla S.C.
Imola (Bo)
8 100%
DE RA
IT
45
Ultradent Products, Inc.
Salt Lake City
8 100%
DE
US
46
GC America, Inc.
Alsip
8 100%
DE
US
47
Spident Co., Ltd.
Incheon
8 100%
DE
KR
48
Align Technology, Inc.
San Jose
8 100%
DE
US
49
Medcad
Dallas
8 100%
DE NE OR
US
50
Izenimplant Co., Ltd.
Pyeongtaek-Si
8 100%
DE
KR

About This FDA 510(k) Manufacturer Database

Data Source and Methodology

Rankings are based on the total number of published FDA 510(k) submissions per manufacturer in the 510k Database dataset, derived from FDA 510(k) public files. This is not a curated or paid listing - manufacturer rankings reflect real regulatory activity.

Used by regulatory affairs teams and medtech consultants to benchmark manufacturer activity, identify predicate device candidates, and analyze competitive positioning across FDA review panels.