510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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EMAClass II

Cement, Dental

21 CFR 872.3275 / Dental
FDA source (opens on fda.gov)

EMA is the FDA product code for Cement, Dental, a class II device type, regulated under 21 CFR 872.3275. As of , FDA records hold 508 510(k) clearances under this code, the most recent dated , and 16 recalls.

Classification record

Product code
EMA
Device name
Cement, Dental
Regulation
21 CFR 872.3275
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
509
Ingested recalls
16

Clearances, product code EMA

By decision year
509 clearances under product code EMA with a decision year between 1976 and 2026, 1998 the highest year at 28.
Show the numbers
510(k) clearances under FDA product code EMA by decision year
YearClearances
19762
19776
19783
19794
19808
19819
19824
19836
19846
19855
19868
19878
198818
19899
199023
199110
199214
199315
199422
199519
199613
199716
199828
199911
200010
200121
20029
200317
200413
20059
200613
20076
200813
200910
201014
20118
201210
201312
20144
20159
201610
20173
20183
20197
20208
20214
20227
20232
20243
202510
20267

Applicants with the most clearances

Product code EMA
Applicants holding the most 510(k) clearances under product code EMA
ApplicantClearances
GC America Inc.30
Shofu Dental Corp.24
Dentsply Intl.19
Sybron Dental Specialties, Inc.16
Pulpdent Corporation14
Voco GmbH13
Espe GmbH (US)10
Coltene /Whaledent AG9
Ivoclar North America, Inc.9
Scientific Pharmaceuticals, Inc.9

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 137 companies shown, in name order