Instruments, Dental Hand
Dental Hand Instruments are a broad category of hand-held, non-powered tools used by dental clinicians for examining, scaling, probing, carving, and otherwise manipulating teeth and oral tissues during preventive and restorative dental procedures. They are classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is DZN and the applicable regulation is 21 CFR 872.4565, under the Dental medical specialty.
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Basic Information
- Product Code
- DZN
- Device Class
- FDA class 1
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 16 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K111465 | COMPOTHIXO | Jul 25, 2012 | Substantially Equivalent | Kerrhawe SA |
| K071858 | DENTAL MATRIX BAND | Aug 31, 2007 | Substantially Equivalent | Fly Cast Technologies, Inc. |
| K901919 | CONTACT MOLAR BANDS AND CONTOUR STRIPS | Jun 22, 1990 | Substantially Equivalent | Ivoclar North America, Inc. |
| K861581 | CENTRIX PCR MOLAR MATRIX FORMS (BANDS) | May 12, 1986 | Substantially Equivalent | Centrix, Inc. |
| K844324 | TIGER BAND | Dec 03, 1984 | Substantially Equivalent | World Wide Outdoor Marketing |
| K840984 | INTERDENTAL WEDGES | Apr 13, 1984 | Substantially Equivalent | Healthco, Inc. |
| K822094 | DENTAL MATRIX BAND | Aug 16, 1982 | Substantially Equivalent | Dentsply Intl. |
| K821444 | COLORED WEDGE USED TO SEPARATE TEETH | Jun 14, 1982 | Substantially Equivalent | Moyco Industries, Inc. |
| K801142 | PALODENT MATRICES & BITINE RINGS | Aug 07, 1980 | Substantially Equivalent | Alvin Meyer, D.D.S. |
| K801530 | COREFORM MOLDS | Jul 28, 1980 | Substantially Equivalent | Sybron Corp. |
| K790555 | HEMO-WEDGE | Jan 17, 1980 | Substantially Equivalent | Parker Laboratories, Inc. |
| K790600 | HOWMEDICA STRIP CROWN | May 21, 1979 | Substantially Equivalent | Howmedica Corp. |
| K790599 | RUWA MATRIX STRIPS | May 21, 1979 | Substantially Equivalent | Howmedica Corp. |
| K790633 | ACCOR MATRIX | May 17, 1979 | Substantially Equivalent | Accor, Inc. |
| K772316 | MATRIX STRIP, DEAD-SOFT | Jan 03, 1978 | Substantially Equivalent | Den-Mat Corp. |
| K772314 | WEDGES, RETAINING, MATRIX | Jan 03, 1978 | Substantially Equivalent | Den-Mat Corp. |
FEI Numbers
This FDA classification entry is associated with 371 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 371 registration numbers. Click on an entry to view related FDA registrations.