Mirror, Mouth
The Mouth Mirror is a hand-held dental instrument with a small reflective head used by dental clinicians to gain indirect visualization of oral structures that cannot be directly seen, and to retract soft tissues during examination and treatment. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is EAX and the applicable regulation is 21 CFR 872.4565, under the Dental medical specialty.
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Basic Information
- Product Code
- EAX
- 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 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K946073 | ORALVUE DENTAL MIRROR | Feb 16, 1995 | Substantially Equivalent | Hines Group , Ltd. |
| K935906 | RANIR PLAX RX | Sep 02, 1994 | Substantially Equivalent | Ranir/Dcp Corp. |
| K941574 | RETRO MIRROR | May 18, 1994 | Substantially Equivalent | Union Broach, Div. Moyco Industries, Inc. |
| K935687 | NIL | Feb 03, 1994 | Substantially Equivalent | Dentalsafe Systems Pty., Ltd. |
| K863767 | GLASS MOUTH MIRRORS, REUSABLE | Oct 30, 1986 | Substantially Equivalent | The Medical Group, Inc. |
| K863766 | DISPOSABLE MOUTH MIRRORS, SINGLE USE ONLY | Oct 30, 1986 | Substantially Equivalent | The Medical Group, Inc. |
| K833310 | FOGCUTTER DENTAL MOUTH MIRROR | May 07, 1984 | Substantially Equivalent | Hti, Inc. |
| K841199 | FIBERGLASS MOUTH MIRRORS | Apr 25, 1984 | Substantially Equivalent | Henry Schein, Inc. |
| K833429 | PERI MIRROR/SALIVA EJECTOR | Dec 22, 1983 | Substantially Equivalent | Dentec, Inc. |
| K830777 | ELECTRIC MOUTH MIRROR | Apr 06, 1983 | Substantially Equivalent | Almore Intl., Inc. |
| K821777 | BEACH MOUTH MIRROR | Jul 06, 1982 | Substantially Equivalent | Pacific Dental Corp. |
| K800919 | ORAVIEW BY WATER PIK | May 08, 1980 | Substantially Equivalent | Teledyne, Inc. |
FEI Numbers
This FDA classification entry is associated with 357 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 357 registration numbers. Click on an entry to view related FDA registrations.