510(k) K051207
- Device
- CAVEX ORTHOTRACE
- Applicant
- Cavex Holland BV
- 510(k) number
- K051207
- Product code
- ELW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-06-21
- Date received
- 2005-05-11
- Regulation
- 872.3660
- Classification name
- Material, Impression
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- RICHARD WOORTMAN
- Address
- Harmenjansweg 19 P.O. Box 852 Haarlem NL 2003 RW 2003 RW
FDA Registration Numbers
- 3025307990
- 3008912871
- 3007743883
- 9680144
- 9612300
- 1032227
- 3005172141
- 3006316962
- 3011689956
- 2014676
- 3005665377
- 3035693034
- 3011500388
- 3004884150
- 3003449480
- 3003941201
- 9680845
- 3012312751
- 3018507299
- 3016447764
- 3006191485
- 8020994
- 3012187973
- 9611385
- 1718476
- 1718912
- 8044164
- 3006223010
- 3003775534
- 3012041047
- 3011050570
- 3030159375
- 3011187729
- 3011649314
- 4565
- 2437780
- 9616065
- 3022516928
- 3004443427
- 2023950
- 3032911850
- 9614977
- 3002785217
- 8021038
- 3009496224
- 3010864832
- 9610902
- 3020749939
- 2024980
- 3010131268
- 1530561
- 1450653
- 3012477813
- 3003618527
- 3014615644
- 3032435508
- 3007353764
- 9681210
- 2244812
- 3012421607
- 2087259
- 3009432160
- 2523320
- 1281412
- 3042272797
- 3008648418
- 1410097
- 3008922120
- 3006113314
- 8021851
- 9681356
- 3031841433
- 2921595
- 3032193293
- 9614794
- 3005628474
- 8010908
- 2126683
- 9681254
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON
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