510(k) K833955
- Device
- Novel Dispenser/package
- Applicant
- DENTSPLY INTL.
- 510(k) number
- K833955
- Product code
- EIY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-01-03
- Date received
- 1983-11-16
- Regulation
- 872.4565
- Classification name
- Instrument, Filling, Plastic, Dental
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3038718579
- 3008882689
- 3004425647
- 3023443842
- 3004215117
- 3006410968
- 2431166
- 2024980
- 2080222
- 3006059835
- 1421879
- 3009703496
- 3004892425
- 3003038445
- 2511556
- 8040278
- 3008388427
- 3012101664
- 8010099
- 3015422158
- 3009049852
- 3014615697
- 3003963832
- 9681540
- 9611283
- 3004193466
- 9613926
- 8010468
- 3007597038
- 3004598675
- 8040881
- 3015136927
- 9615399
- 3015060193
- 3031582434
- 3010055973
- 3003244954
- 8010159
- 3001146947
- 3009340886
- 3015895045
- 3009255580
- 3006990004
- 3012312751
- 3008808049
- 3002808270
- 3001297506
- 3027556548
- 2921595
- 3006264569
- 3002675176
- 3001620590
- 9680507
- 3003120666
- 2521453
- 3016114530
- 3004168759
- 8010704
- 9616704
- 9611899
- 3002769844
- 3013946322
- 3031191035
- 3014937043
- 8041151
- 1836088
- 9680304
- 3030405669
- 1836161
- 3014953747
- 9614075
- 3029082594
- 1937100
- 3005554774
- 1419489
- 3010288346
- 3012421607
- 3005092287
- 1419982
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EIY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K871909 | COMPOSITE RESTORATIVE CARRIER | Dentsply Intl. | 1987-05-27 |
| K851726 | 1760/1 TO 2010/34 VARIOUS DENTAL FILLING INSTRUMEN | Artiberia | 1985-07-02 |
| K830776 | MICROFIL CONTOURING INSTRUMENTS | Almore Intl., Inc. | 1983-04-28 |
| K823323 | DENTAL INSTRUMENTS - PLASTIC INSTRUMENTS | Miltex, Inc. | 1982-11-24 |