510(k) K840984
- Device
- Interdental Wedges
- Applicant
- HEALTHCO, INC.
- 510(k) number
- K840984
- Product code
- DZN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-04-13
- Date received
- 1984-03-06
- Regulation
- 872.4565
- Classification name
- Instruments, Dental Hand
- 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#
- 1051614
- 1720747
- 3010442693
- 3003971538
- 3011210208
- 3004046477
- 3004892425
- 1419982
- 3004109528
- 3004361903
- 3043648115
- 3010583458
- 1424785
- 3043226252
- 3010455030
- 3009827000
- 1833132
- 3015512299
- 8032033
- 3002090132
- 2133714
- 3012187973
- 3043149181
- 2429849
- 3003882387
- 8010422
- 8031058
- 3013528406
- 2416455
- 3011789026
- 8010629
- 3049552730
- 3016112537
- 8044058
- 3002808270
- 3024787345
- 2916735
- 2032006
- 1421101
- 3011554142
- 8040179
- 3026760
- 3005581016
- 3029901632
- 3017181138
- 3006207978
- 3005809810
- 3013508670
- 3009384933
- 3004598675
- 3024088964
- 1412854
- 2126387
- 3009491780
- 3044819802
- 8030938
- 3027556548
- 3006444232
- 3030056132
- 8010445
- 1718912
- 3009171220
- 3005528784
- 2511556
- 3042244574
- 3001297506
- 3003678542
- 3010687973
- 3010453282
- 3021630667
- 1223843
- 1056350
- 3011936113
- 8010516
- 3038191347
- 9680515
- 2020550
- 8031054
- 3010610239
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DZN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K111465 | COMPOTHIXO | Kerrhawe SA | 2012-07-25 |
| K071858 | DENTAL MATRIX BAND | Fly Cast Technologies, Inc. | 2007-08-31 |
| K901919 | CONTACT MOLAR BANDS AND CONTOUR STRIPS | Ivoclar North America, Inc. | 1990-06-22 |
| K861581 | CENTRIX PCR MOLAR MATRIX FORMS (BANDS) | Centrix, Inc. | 1986-05-12 |
| K844324 | TIGER BAND | World Wide Outdoor Marketing | 1984-12-03 |
| K822094 | DENTAL MATRIX BAND | Dentsply Intl. | 1982-08-16 |
| K821444 | COLORED WEDGE USED TO SEPARATE TEETH | Moyco Industries, Inc. | 1982-06-14 |
| K801142 | PALODENT MATRICES & BITINE RINGS | Alvin Meyer, D.D.S. | 1980-08-07 |
| K801530 | COREFORM MOLDS | Sybron Corp. | 1980-07-28 |
| K790555 | HEMO-WEDGE | Parker Laboratories, Inc. | 1980-01-17 |
| K790599 | RUWA MATRIX STRIPS | Howmedica Corp. | 1979-05-21 |
| K790600 | HOWMEDICA STRIP CROWN | Howmedica Corp. | 1979-05-21 |
| K790633 | ACCOR MATRIX | Accor, Inc. | 1979-05-17 |
| K772314 | WEDGES, RETAINING, MATRIX | Den-Mat Corp. | 1978-01-03 |
| K772316 | MATRIX STRIP, DEAD-SOFT | Den-Mat Corp. | 1978-01-03 |