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#
- 3011164188
- 2531684
- 3011554142
- 9610809
- 8041151
- 3012421607
- 3012628066
- 3009049852
- 3009703496
- 3008902714
- 9611899
- 3012101664
- 8010159
- 3042244574
- 9611062
- 2183301
- 3006059835
- 2431166
- 2521453
- 3032747418
- 3011371465
- 3011625373
- 3011707926
- 3003807268
- 3010147274
- 3013497507
- 3014683120
- 3008882689
- 3005067367
- 3005897698
- 3003431869
- 3002769835
- 1000492377
- 3031184338
- 3013463240
- 3009937681
- 2916714
- 3001620590
- 3043047788
- 9680913
- 3014953747
- 3003969055
- 2024312
- 9680304
- 2246990
- 3005973280
- 3004425647
- 3017352116
- 3009255580
- 3007751820
- 3003963832
- 8040233
- 3002769844
- 3003334541
- 3044819802
- 3008242564
- 3010864832
- 8010468
- 3003882387
- 9680002
- 3031191035
- 9680735
- 3003407244
- 3029082594
- 3006990004
- 9613208
- 3013946322
- 3003120666
- 8040881
- 9681540
- 3044150131
- 8031010
- 3005621335
- 9611283
- 3011499367
- 9614075
- 3003877407
- 3030126955
- 3015422158
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 |