510(k) K820104
- Device
- Nupro* Gel Tray
- Applicant
- JOHNSON & JOHNSON PROFESSIONALS, INC.
- 510(k) number
- K820104
- Product code
- KMT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-02-23
- Date received
- 1982-01-15
- Regulation
- 872.6870
- Classification name
- Tray, Fluoride, Disposable
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 325 Paramount Dr. Raynham MA US 02767 02767
FDA Registration Numbers#
- 3005176727
- 3014270094
- 3021023132
- 3015134890
- 3012205930
- 3004425647
- 1941138
- 3009219448
- 9611959
- 3010131268
- 3009171220
- 1319130
- 3015276580
- 3007255375
- 3008559238
- 3011632
- 3005663102
- 3016170492
- 3017903664
- 2024980
- 3006750855
- 3038718579
- 3009420946
- 3004046477
- 3006847937
- 3012133441
- 2086043
- 1051614
- 3010147274
- 3015134891
- 1316408
- 2433629
- 2018957
- 3016447764
- 3013181723
- 2031508
- 3010583458
- 3015330571
- 3008081327
- 3015491448
- 3023443842
- 3027234828
- 2133714
- 2437780
- 3007177751
- 3003487388
- 1000380364
- 3016986305
- 3027650644
- 2435946
- 3024088964
- 3015456817
- 3005167547
- 2024312
- 2523320
- 3025307990
- 3006608997
- 8044058
- 3005558160
- 8040278
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KMT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K031809 | PERIO PROTECT TRAY | Perio Protect, LLC | 2004-01-23 |
| K904914 | DENTAL VACUUM INJECTION TRAY | The Lebanon Vac-Tray Corp. | 1990-12-17 |
| K871784 | TOP FORM II TRAYS, DISPOS FOAM-LINED TOP GEL APPLI | Colgate-Hoyt Laboratories | 1987-05-27 |
| K853882 | SUPER SLICK | Tang Products | 1985-11-18 |
| K811154 | HOYT ECONO-TRAY | Hoyt Laboratories | 1981-05-13 |
| K780712 | KERR DISCOVERY DISPOSABLE FLUORIDE TRAY | Kerr Corporation (Danbury) | 1978-05-17 |
| K770064 | FLUORIDE GEL DISPOSABLE TRAY | Lorvic Corp. | 1977-01-14 |