510(k) K090684
- Device
- AVANTE LEUCITE BLOCKS
- Applicant
- Somerset Dental Products, Inc.
- 510(k) number
- K090684
- Product code
- EIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-05-01
- Date received
- 2009-03-16
- Regulation
- 872.6660
- Classification name
- Powder, Porcelain
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CINDY SALTER
- Address
- 500 Memorial Dr. Somerset NJ US 08873 08873
FDA Registration Numbers#
- 1718912
- 3027481489
- 3035983708
- 3000219976
- 3002807050
- 3034244245
- 3003449480
- 3009482106
- 1420052
- 3014980456
- 3004966444
- 2082832
- 3023272670
- 1222802
- 3017450159
- 3013934196
- 2433919
- 8031058
- 2436986
- 3009740550
- 3010127342
- 3015108415
- 3015194291
- 3030464310
- 3002889488
- 3025604798
- 3009081830
- 1000118628
- 3012187973
- 3019784699
- 3004905070
- 3013513796
- 1219645
- 3013551048
- 3035693034
- 3012441963
- 3030515618
- 2023817
- 1000625496
- 3008912871
- 9681199
- 3024185724
- 3005554774
- 3018252381
- 3022082678
- 3015332784
- 3014945384
- 3005904906
- 3027341558
- 3024792419
- 3031595584
- 3034729565
- 3005974404
- 3003775534
- 2018957
- 3012867029
- 3004884150
- 8010711
- 9613348
- 3034729999
- 3009312656
- 3011649314
- 3032163716
- 3008383146
- 3017674095
- 3009643402
- 2023129
- 9611458
- 3031915955
- 3015978392
- 3006146796
- 3031606428
- 9611385
- 3008320092
- 3009409473
- 3025436468
- 3040605150
- 3011824442
- 3006223010
- 2523320
Source Documents#
510(k) summary PDF not indicated by FDA
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