PREFORMED TOOTH POSITIONER
FDA 510(k) clearance K780619 · decided 1978-06-28
Clearance details
- K-number
- K780619
- Device name
- PREFORMED TOOTH POSITIONER
- Applicant
- Tp Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-04-13
- Decision date
- 1978-06-28
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- KMY
- Device class
- 1
- Regulation number
- 872.5525
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NITE-GUIDE (K931615) | ORTHO-TAIN, Inc. | 1995-04-14 |
| DENT-O-CRYL ORTHODONTIC ACRYLIC (K942667) | Dentauraum, Inc. | 1995-02-13 |
| GLENROE ELASTIBITE STIMULATOR (K924351) | Glenroe Technologies | 1994-01-06 |
| RELAX-O-GUARD (K925064) | Aquatemp Service Co., Inc. | 1993-09-13 |
| THE ORTHOTRAINER (K924975) | Myofunctional Research Corp. Pty. , Ltd. | 1993-07-08 |
| THE TMJ APPLIANCE (K924974) | Myofunctional Research Corp. Pty. , Ltd. | 1993-06-23 |
| PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER (K904128) | American Orthodontics | 1990-11-09 |
| PREFORMED TEMPLATE FOR TOOTH POSITIONER (K891328) | American Orthodontics | 1989-03-31 |
| REMOLDABLE CRANIOMANDIBULAR APPLIANCE (K833455) | Jeffrey H. Attlin | 1984-01-10 |
| AQUALIZER MOUTHPIECE (K831793) | Martin D. Lerman | 1983-08-12 |
| DYNAMIC FUNTIONAL POSITIONER (K821458) | Dynamic Functional Positioner, Inc. | 1982-06-09 |
Recalls involving this device
No recalls on record reference this clearance.