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#
- 9616538
- 3005581016
- 3005831677
- 3044819802
- 3004046512
- 3014620201
- 3011526299
- 1250045
- 3004892425
- 2024312
- 8010422
- 3015491448
- 3001146947
- 3045857207
- 3015422158
- 2183301
- 2241860
- 3010453282
- 3009420946
- 3003334541
- 3011600579
- 3010583458
- 9611450
- 9610612
- 8043971
- 2435118
- 9680507
- 1410097
- 3023443842
- 8010516
- 1833132
- 8032033
- 3013641573
- 3008254125
- 3003120666
- 8040278
- 2431166
- 3013557562
- 1051594
- 3011210208
- 3003855981
- 3002808270
- 3043625057
- 3021630667
- 3036795921
- 2086043
- 1836161
- 2521453
- 3008882689
- 3005809810
- 3003038445
- 3005558160
- 3007622273
- 3009538961
- 3007126709
- 1419247
- 3008910197
- 3018258389
- 3029082594
- 3002090132
- 3024787345
- 3014342096
- 3035693034
- 3008346537
- 3001295407
- 3009161350
- 3012494290
- 8043554
- 8010638
- 1421101
- 8040179
- 3012771684
- 2916714
- 3007320533
- 3003882399
- 2018957
- 1066741
- 3014643275
- 3007167099
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