510(k) K801142
- Device
- PALODENT MATRICES & BITINE RINGS
- Applicant
- ALVIN MEYER, D.D.S.
- 510(k) number
- K801142
- Product code
- DZN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-08-07
- Date received
- 1980-05-13
- 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#
- 9614069
- 9611899
- 3004730002
- 2020550
- 9680718
- 3015895045
- 3012441963
- 9616250
- 1627417
- 1836161
- 3004623350
- 3023443842
- 8041151
- 3010864832
- 3005973280
- 3012187973
- 1281412
- 3011625373
- 3009420946
- 3008590661
- 2531684
- 3017181138
- 1526352
- 3027320022
- 3003694926
- 2523320
- 2529846
- 3014829979
- 3001297506
- 3012771684
- 8010516
- 3011632
- 1032347
- 3005558160
- 3017604
- 2032006
- 3010583458
- 3026400121
- 3003882387
- 3003969055
- 3002090132
- 3014326245
- 3008912871
- 2918719
- 3043625057
- 3011434305
- 3006707038
- 3009340886
- 3012421607
- 3001146947
- 9680002
- 1250045
- 3003038445
- 1419982
- 3013641573
- 3032911850
- 3012896103
- 3007622273
- 3010442693
- 1419247
- 3021245739
- 8010638
- 3008338766
- 3004425647
- 3009049852
- 2916714
- 1410097
- 9616538
- 1833132
- 9611385
- 3005528784
- 3008910197
- 3003418325
- 9680244
- 3043533459
- 1036212
- 2429849
- 3005621335
- 3008261720
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 |
| K840984 | INTERDENTAL WEDGES | Healthco, Inc. | 1984-04-13 |
| K822094 | DENTAL MATRIX BAND | Dentsply Intl. | 1982-08-16 |
| K821444 | COLORED WEDGE USED TO SEPARATE TEETH | Moyco Industries, Inc. | 1982-06-14 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases