The following data is part of a premarket notification filed by Elos Medtech Pinol A/s with the FDA for Elos Accurate Hybrid Base.
Device ID | K191919 |
510k Number | K191919 |
Device Name: | Elos Accurate Hybrid Base |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | Elos Medtech Pinol A/S Engvej 33 Gorlose, DK Dk-3330 |
Contact | Tina Friis Poulsen |
Correspondent | Floyd G. Larson PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-07-18 |
Decision Date | 2020-02-10 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05712821002327 | K191919 | 000 |
05712821000545 | K191919 | 000 |
05712821000538 | K191919 | 000 |
05712821000521 | K191919 | 000 |
05712821000514 | K191919 | 000 |
05712821000507 | K191919 | 000 |
05712821000491 | K191919 | 000 |
05712821000484 | K191919 | 000 |
05712821000477 | K191919 | 000 |
05712821000439 | K191919 | 000 |
05712821000422 | K191919 | 000 |
05712821000415 | K191919 | 000 |
05712821000408 | K191919 | 000 |
05712821000392 | K191919 | 000 |
05712821000385 | K191919 | 000 |
05712821000378 | K191919 | 000 |
05712821000361 | K191919 | 000 |
05712821000354 | K191919 | 000 |
05712821001184 | K191919 | 000 |
05712821001191 | K191919 | 000 |
05712821001214 | K191919 | 000 |
05712821002310 | K191919 | 000 |
05712821002266 | K191919 | 000 |
05712821002204 | K191919 | 000 |
05712821002198 | K191919 | 000 |
05712821002181 | K191919 | 000 |
05712821002167 | K191919 | 000 |
05712821002150 | K191919 | 000 |
05712821002143 | K191919 | 000 |
05712821002136 | K191919 | 000 |
05712821002129 | K191919 | 000 |
05712821002112 | K191919 | 000 |
05712821002105 | K191919 | 000 |
05712821001269 | K191919 | 000 |
05712821001252 | K191919 | 000 |
05712821001245 | K191919 | 000 |
05712821001238 | K191919 | 000 |
05712821001221 | K191919 | 000 |
05712821000347 | K191919 | 000 |