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#
- 3009937681
- 1718912
- 3002769844
- 3038191347
- 3004168759
- 9710524
- 3009049852
- 9680304
- 3012312751
- 8040881
- 1416605
- 9611283
- 9614075
- 3002808270
- 3014829979
- 2024980
- 3011164188
- 3002769835
- 9680735
- 3008352964
- 1032227
- 3011499367
- 3003418325
- 9613208
- 3004425647
- 1000492377
- 3003877407
- 3011625373
- 3008808049
- 1422507
- 2431166
- 3004598675
- 2433629
- 3030405669
- 8010704
- 9615399
- 3009968482
- 3011707926
- 3011279497
- 2921595
- 2183301
- 1281412
- 3005973280
- 3010147274
- 9616128
- 3015895045
- 3045855232
- 3009703496
- 3016965929
- 3008902714
- 3003334541
- 3013552516
- 2320721
- 8041151
- 8010159
- 3030089802
- 9680002
- 2084346
- 2521453
- 1419982
- 3005067367
- 3008882689
- 3001297506
- 8010732
- 1937100
- 3038632739
- 3012101664
- 3005554774
- 3031582434
- 3012628066
- 3021023132
- 1036212
- 3019404837
- 3010288346
- 2916714
- 1419489
- 3003807268
- 2024312
- 3031184338
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 |