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#
- 3006990004
- 8043554
- 8040278
- 3011164188
- 3023443842
- 2024980
- 3010864832
- 3031184338
- 3010055973
- 3030126955
- 9610809
- 3003963832
- 3004215117
- 3016965929
- 9616119
- 3005897698
- 3031191035
- 3005621335
- 1718912
- 3001146947
- 2531684
- 3003431869
- 1937100
- 3031582434
- 3005809810
- 3009420946
- 3003969055
- 3038718579
- 3043047788
- 1000492377
- 3002808270
- 3011526299
- 3017352116
- 9611062
- 3002675176
- 8010468
- 9615399
- 3044819802
- 3001297506
- 3005554774
- 3029082594
- 3011625373
- 3017618678
- 9681540
- 3012628066
- 9613079
- 1422507
- 3003334541
- 3015060193
- 2511556
- 2916714
- 9614075
- 2521453
- 3011707926
- 3024088964
- 3014615697
- 3014953747
- 3017138012
- 3003882387
- 3042244574
- 3008770252
- 2080222
- 3045857207
- 1416605
- 3007597038
- 9680913
- 3013497507
- 3008882689
- 3008352964
- 3009937681
- 3003877407
- 3024946194
- 3002807757
- 8040881
- 3006264569
- 9680424
- 3030405669
- 3009049852
- 3010155661
- 8041151
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 |