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#
- 3005497913
- 1054986
- 1419247
- 3007320533
- 3010864832
- 3001297506
- 1223843
- 3009420946
- 3008370577
- 3003956316
- 3043648115
- 3005528784
- 3005665377
- 3008338766
- 3004362235
- 3009538961
- 3021245739
- 3008887731
- 3005092287
- 3013508670
- 3014620201
- 8031054
- 3015895045
- 2017608
- 1051594
- 2024980
- 3011526299
- 2246990
- 2032006
- 3010455030
- 3004201548
- 3009268271
- 3038191347
- 3010055973
- 3003969055
- 2916735
- 3021630667
- 9614986
- 3013734586
- 3042244574
- 3036269993
- 3009340886
- 2529846
- 1281412
- 2531684
- 3014829979
- 3010442693
- 3021368823
- 3025325119
- 3015512299
- 3003971538
- 3021386681
- 3007126709
- 3023443842
- 8010422
- 3010155661
- 8040179
- 3006707038
- 3038632739
- 3044819802
- 3039433962
- 3010687973
- 3021169199
- 3011625373
- 3016112537
- 3021076825
- 3010610239
- 3017910185
- 1250045
- 3009384933
- 3012771684
- 9680026
- 3010583458
- 3026760
- 3016750628
- 8010159
- 1836088
- 3008910197
- 8030938
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