510(k) K063003
- Device
- AURORA
- Applicant
- Parkell, Inc.
- 510(k) number
- K063003
- Product code
- EBZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-11-28
- Date received
- 2006-10-02
- Regulation
- 872.6070
- Classification name
- Activator, Ultraviolet, For Polymerization
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- DANIEL R SCHECHTER
- Address
- 300 Executive Dr. Edgewood NY US 11717 11717
FDA Registration Numbers#
- 1410097
- 3006984716
- 9612352
- 3002807636
- 1420089
- 3006847937
- 9710363
- 3009307635
- 3012187973
- 3003933619
- 3007113232
- 3016075921
- 3005665377
- 3012771684
- 3008770655
- 3003169405
- 3003637274
- 3002807050
- 3003694926
- 3002957626
- 1937100
- 3004884150
- 1836088
- 2024949
- 3019381139
- 8010908
- 1718476
- 3038718579
- 8044015
- 9615399
- 3013641573
- 3005515469
- 2411797
- 1000493628
- 3010864832
- 3006654680
- 3032027578
- 3011300255
- 2031508
- 3027234828
- 2515379
- 3005581016
- 3043226252
- 3007007357
- 2416455
- 9680864
- 8044167
- 8043962
- 1032227
- 3004425647
- 9612300
- 9614977
- 3004082121
- 2126683
- 3007663058
- 2523990
- 8010638
- 3030126955
- 3014953747
- 3005972890
- 3006186796
- 3016543896
- 3011824442
- 2183301
- 2133714
- 3035693034
- 1718912
- 3007284437
- 3000219976
- 3023861999
- 3007662989
- 3006113314
- 3009496224
- 3022516928
- 1419489
- 3006621353
- 3009142030
- 9611385
- 3016875543
- 9681479
Source Documents#
510(k) summary PDF not indicated by FDA
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