Name: FDA 510(k) Medical Device Manufacturers
Creator: 510k Database

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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FDA 510(k) Dental Manufacturers

1–50 of 891

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Siemens Medical Solutions USA, Inc. Hoffman Estates	782	100%	AN CV DE +4	US
2	Smith & Nephew, Inc. Mchenry	530	98%	CV DE EN +9	US
3	Baxter Healthcare Corp Mchenry	505	100%	AN CH CV +14	US
4	Medtronic Vascular Walker	475	97%	AN CH CV +9	US
5	Biomet, Inc. Mchenry	441	95%	CV DE EN +9	US
6	Synthes (Usa) Mchenry	411	96%	DE HO NE +3	US
7	Howmedica Corp. Mchenry	373	87%	CV DE EN +7	US
8	KARL STORZ Endoscopy-America, Inc. Mchenry	362	100%	AN CV DE +9	US
9	3M Company White City	331	98%	AN CH CV +12	US
10	Depuy, Inc. Mchenry	303	79%	CV DE GU +6	US
11	Dentsply Intl. Walker	279	100%	AN DE HO +4	US
12	Argen Precious Metals, Inc. San Diego	217	100%	DE	US
13	Aesculap, Inc. Burlingame	207	97%	CV DE GU +5	US
14	Travenol Laboratories, S.A. Mchenry	206	100%	AN CH CV +9	US
15	Johnson & Johnson Professionals, Inc. Raynham	206	89%	CH CV DE +9	US
16	Ethicon, Inc. Raritan	205	98%	CV DE EN +6	US
17	Sherwood Medical Co. Mchenry	191	99%	AN CH CV +10	US
18	Exactech, Inc. Gainesville	186	94%	DE OR	US
19	Respironics, Inc. Monroeville	172	98%	AN CH CV +6	US
20	Medtronic Sofamor Danek USA, Inc. Memphis	171	100%	DE HO NE +3	US
21	W.L. Gore & Associates, Inc. Mchenry	163	93%	CV DE EN +8	US
22	Miles Laboratories, Inc. Mchenry	158	100%	CH DE HE +6	US
23	Medtronic Sofamor Danek Memphis	154	99%	DE NE OR +1	US
24	Codman & Shurtleff, Inc. Mchenry	152	100%	CV DE GU +8	US
25	Heraeus Kulzer, Inc. Elkhart	145	100%	CH DE HE +3	US
26	Terumo Medical Corp. Elkton	143	100%	AN CH CV +9	US
27	Richard Wolf Medical Instruments Corp. Mchenry	142	100%	AN DE EN +7	US
28	Ivoclar North America, Inc. Amherst	131	100%	DE	US
29	GC America, Inc. Alsip	127	100%	DE	US
30	Wilson-Cook Medical, Inc. Winstrom-Salem	125	99%	AN DE EN +2	US
31	Stryker Corp. Mchenry	124	99%	AN CV DE +9	US
32	Conphar, Inc. Mchenry	122	100%	AN CV DE +9	US
33	Voco GmbH Denver	119	100%	DE	US
34	Arthrocare Corp. Mountain View	112	100%	DE EN GU +3	US
35	Welch Allyn, Inc. Mchenry	111	100%	AN CH CV +8	US
36	Buckman Co., Inc. Mchenry	111	94%	AN CV DE +9	US
37	Stryker Portage	58	100%	DE EN NE +2	US
38	Institut Straumann AG Basel	54	100%	DE HO	CH
39	Dentsply Sirona York	48	100%	DE GU HO +2	US
40	Nobel Biocare AB Goteborg	30	100%	DE HO RA	SE
41	BTL Industries, Inc. Malborough	30	100%	DE GU NE +2	US
42	Prismatik Dentalcraft, Inc. Newport Beach	30	100%	DE HO	US
43	KLS-Martin L.P. Jacksonville	28	100%	DE NE OR	US
44	Materialise NV Leuven	25	100%	DE NE OR +1	BE
45	Dentis Co., Ltd. Dalseo-Gu	25	100%	DE	KR
46	Jjgc Industria E Comercio DE Materiais Dentarios S.A. Curitiba	25	100%	DE HO	BR
47	Jeil Medical Corporation Deer Field	23	100%	DE OR	US
48	Megagen Implant Co., Ltd. Santa Fe Springs	22	100%	DE RA	US
49	Dentsply Sirona, Inc. York	21	100%	DE HO RA	US
50	Terrats Medical SL Montcada I Reixac	21	100%	DE	ES

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.