Product code EAX
- Device name
- Mirror, Mouth
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.4565
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K946073 | ORALVUE DENTAL MIRROR | Hines Group , Ltd. | 1995-02-16 |
| K935906 | RANIR PLAX RX | Ranir/Dcp Corp. | 1994-09-02 |
| K941574 | RETRO MIRROR | Union Broach, Div. Moyco Industries, Inc. | 1994-05-18 |
| K935687 | NIL | Dentalsafe Systems Pty., Ltd. | 1994-02-03 |
| K863766 | DISPOSABLE MOUTH MIRRORS, SINGLE USE ONLY | The Medical Group, Inc. | 1986-10-30 |
| K863767 | GLASS MOUTH MIRRORS, REUSABLE | The Medical Group, Inc. | 1986-10-30 |
| K833310 | FOGCUTTER DENTAL MOUTH MIRROR | Hti, Inc. | 1984-05-07 |
| K841199 | FIBERGLASS MOUTH MIRRORS | Henry Schein, Inc. | 1984-04-25 |
| K833429 | PERI MIRROR/SALIVA EJECTOR | Dentec, Inc. | 1983-12-22 |
| K830777 | ELECTRIC MOUTH MIRROR | Almore Intl., Inc. | 1983-04-06 |
| K821777 | BEACH MOUTH MIRROR | Pacific Dental Corp. | 1982-07-06 |
| K800919 | ORAVIEW BY WATER PIK | Teledyne, Inc. | 1980-05-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08961104622944 | Dental Mouth Mirror | MELPEX BEAUTY INSTRUMENTS | 2026-05-21 |
| 08961104622586 | Dental Mouth Mirror | MELPEX BEAUTY INSTRUMENTS | 2026-05-21 |
| 08961104622579 | Dental Mouth Mirror | MELPEX BEAUTY INSTRUMENTS | 2026-05-21 |
| G149TBSB3140 | TBS BASICS | ACME ENTERPRISE. | 2026-05-16 |
| G149TBSB3130 | TBS BASICS | ACME ENTERPRISE. | 2026-05-16 |
| G149TBSB3120 | TBS BASICS | ACME ENTERPRISE. | 2026-05-16 |
| G149TBSB3110 | TBS BASICS | ACME ENTERPRISE. | 2026-05-16 |
| G1577072350 | Pomee | POMEE CORPORATION | 2021-12-30 |
| ESAM4834001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM7984001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM7982001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4970081 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4964001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4955001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM34964001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4835001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4854001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4855001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4856001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4924001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4934001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4935001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4944001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4945001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4954001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4956001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| 10304040130510 | Henry Schein | HENRY SCHEIN, INC. | 2020-03-27 |
| 10304040130527 | Henry Schein | HENRY SCHEIN, INC. | 2020-03-27 |
| 10304040130534 | Henry Schein | HENRY SCHEIN, INC. | 2020-03-27 |
| 10304040057015 | Henry Schein | HENRY SCHEIN, INC. | 2019-01-31 |