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#
- 3031582434
- 1000492377
- 3024946194
- 3011707926
- 3012628066
- 3010864832
- 3001297506
- 2921595
- 3008388427
- 3009420946
- 3008352964
- 3003882387
- 3002807757
- 3004168759
- 3004215117
- 3043239665
- 2431166
- 3016114530
- 9710524
- 9611367
- 3022862651
- 3016965929
- 3005092287
- 3003418325
- 3004892425
- 3008808049
- 9616128
- 3038718579
- 3015895045
- 3007597038
- 3011279497
- 3003963832
- 2521453
- 3008242564
- 3002769835
- 3030126955
- 9680002
- 3003877407
- 3003244954
- 3007064566
- 3002769844
- 9680913
- 9614075
- 2024980
- 3006264569
- 3045857207
- 3006990004
- 3011526299
- 2246990
- 1421879
- 3001146947
- 3009937681
- 3002675176
- 3009968482
- 3027556548
- 3012421607
- 3024088964
- 3010455030
- 3010147274
- 3011164188
- 9613926
- 9680304
- 3038191347
- 3008882689
- 2916714
- 3010055973
- 3003969055
- 3011371465
- 9680507
- 9612086
- 3003038445
- 3042244574
- 2084346
- 3005973280
- 3003487388
- 3042866301
- 8043554
- 3005067367
- 3009340886
- 3011499367
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 |