510(k) K844211
- Device
- Concise Light Cured White Sealant
- Applicant
- 3M COMPANY
- 510(k) number
- K844211
- Product code
- EBC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-01-07
- Date received
- 1984-10-31
- Regulation
- 872.3765
- Classification name
- Sealant, Pit And Fissure, And Conditioner
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- DONALD H MCKENZIE
- Address
- Chemolite Blvd. & Washington City Rd. 19 Cottae Grove MN US 55016 55016
FDA Registration Numbers
- 3002789526
- 3005176727
- 1410097
- 3013584861
- 9612352
- 3006316962
- 1281412
- 3017674095
- 1420052
- 3031841433
- 9681356
- 2241860
- 2086043
- 3013557697
- 3006694515
- 3012187973
- 1424442
- 3005665377
- 9613953
- 3003449480
- 3008912871
- 1215305
- 3010131268
- 3011689956
- 3004967419
- 8010908
- 2511556
- 1000118628
- 3012627824
- 2424472
- 2024980
- 3038718579
- 9681210
- 1000272892
- 3010002722
- 3008966075
- 1721647
- 3006444232
- 2515379
- 3025307990
- 3043226252
- 3013410675
- 8020994
- 9612300
- 1723973
- 1413475
- 3018047916
- 3042244574
- 8044164
- 3007210751
- 3002808149
- 2183301
- 3042272797
- 2133714
- 3012494290
- 1718912
- 9681254
- 3000219976
- 2921595
- 3014615644
- 3009496224
- 2244842
- 3010664129
- 9680845
- 2022039
- 3011430871
- 9610902
- 3032163716
- 3006367836
- 3006805063
- 3016447764
- 1013257
- 3004966444
- 2437780
- 3012996495
- 3012477813
- 3012421607
- 1450653
- 3018507299
Source Documents
510(k) summary PDF not indicated by FDA
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