510(k) K811209
- Device
- JACOB WIRZ TRANSFIXATION PIN
- Applicant
- COLMED, LTD.
- 510(k) number
- K811209
- Product code
- ELS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-06-16
- Date received
- 1981-05-01
- Regulation
- 872.3890
- Classification name
- Splint, Endodontic Stabilizing
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3043303267
- 3012339007
- 3023657851
- 1051614
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ELS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972985 | SPLINT IT | Jeneric/Pentron, Inc. | 1997-09-24 |
| K961704 | MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM | Dentatus USA , Ltd. | 1996-07-26 |
| K922673 | FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDING | Glasspan, Inc. | 1994-02-25 |
| K834363 | ENDIX RADICULAR BIOCERAMIC PIN | C.B.S. Biotechnics, Inc. | 1984-02-27 |
| K801525 | ZEST ENDODONTIC STABILIZER | Zest Anchors, Inc. | 1980-07-21 |
Legacy Summary#
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FDA Review#
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