510(k) K871909
- Device
- Composite Restorative Carrier
- Applicant
- DENTSPLY INTL.
- 510(k) number
- K871909
- Product code
- EIY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-05-27
- Date received
- 1987-05-18
- 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#
- Contact
- JOHN O SEMMELMAN
- Address
- 570 W. College Ave. P.O. Box 872 York PA US 17405 17405
FDA Registration Numbers#
- 3013552516
- 3012312751
- 1281412
- 3008242564
- 9610612
- 3015422158
- 8010704
- 3015512299
- 3006990004
- 3001297506
- 3038632739
- 3027615
- 1419982
- 2431166
- 3005809810
- 3010147274
- 8010159
- 3011707926
- 2433629
- 3009255580
- 3030405669
- 9680913
- 3031582434
- 3005067367
- 3009968482
- 3009049852
- 3007064566
- 3015895045
- 3009937681
- 3012628066
- 3008388427
- 9681540
- 3007751820
- 3002808270
- 3002807757
- 3009703496
- 1422507
- 3011554142
- 2246990
- 3016114530
- 3019404837
- 3021023132
- 3002769835
- 3006264569
- 9616704
- 9710524
- 1937100
- 3011371465
- 1836088
- 3009171220
- 3013497507
- 3002675176
- 3010055973
- 2511556
- 3011526299
- 8031010
- 3014937043
- 9613208
- 2024980
- 8010468
- 3038718579
- 9615399
- 1036212
- 3007597038
- 8043548
- 3004598675
- 3010864832
- 3001146947
- 9680002
- 8040881
- 1416605
- 2084346
- 3005621335
- 3003407244
- 3011625373
- 3010288346
- 3027556548
- 3011279497
- 9611367
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EIY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K851726 | 1760/1 TO 2010/34 VARIOUS DENTAL FILLING INSTRUMEN | Artiberia | 1985-07-02 |
| K833955 | NOVEL DISPENSER/PACKAGE | Dentsply Intl. | 1984-01-03 |
| K830776 | MICROFIL CONTOURING INSTRUMENTS | Almore Intl., Inc. | 1983-04-28 |
| K823323 | DENTAL INSTRUMENTS - PLASTIC INSTRUMENTS | Miltex, Inc. | 1982-11-24 |