510(k) K852894
- Device
- ORMCO TRANSMANDIBULAR IMPLANT
- Applicant
- ORMCO CORP.
- 510(k) number
- K852894
- Product code
- MDL
- Decision
- Se - Postmarket Surveillance Required (SESP)
- Decision date
- 1985-08-29
- Date received
- 1985-07-09
- Regulation
- 872.4760
- Classification name
- Implant, Transmandibular
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WENDELL LEE
- Address
- 1332 S. Lone Hill Ave. Glendora CA US 91740 91740
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MDL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K900433 | SMOOTH STAPLE IMPLANT | Interphase Implants, Inc. | 1990-11-16 |
Legacy Summary#
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FDA Review#
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