510(k) K772314
- Device
- WEDGES, RETAINING, MATRIX
- Applicant
- DEN-MAT CORP.
- 510(k) number
- K772314
- Product code
- DZN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-01-03
- Date received
- 1977-12-19
- 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#
- 3005665377
- 3026326493
- 3045058049
- 3035693034
- 1054986
- 3011824442
- 3003882387
- 3008912871
- 3005809810
- 3005663340
- 8010584
- 8030870
- 3010701675
- 3030056132
- 3014201171
- 1223843
- 3010202439
- 3004158247
- 3036269993
- 3011632
- 9611112
- 3002808270
- 1250045
- 9610617
- 3015422158
- 9612124
- 8010732
- 9611899
- 3007497008
- 3011936113
- 3007622273
- 8010339
- 9616103
- 3043226252
- 3002090132
- 3021169199
- 3015177652
- 9681207
- 2511556
- 3029082594
- 3008882689
- 3024088964
- 8041151
- 3012396434
- 9611367
- 3023852420
- 3007587775
- 1627417
- 9613208
- 3004753334
- 3008370577
- 3031841433
- 3003971538
- 3009307523
- 3012494290
- 3043533459
- 3007126709
- 3042272797
- 3043149181
- 3039433962
- 3013734586
- 3004992978
- 3021076825
- 8020994
- 3004201548
- 3017910185
- 2017665
- 8044058
- 3011789026
- 3009551666
- 3021245739
- 3014937043
- 3013784566
- 3003855981
- 3010896988
- 3003963832
- 5906
- 3014643275
- 2017608
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 |
| 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 |
| 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