The following data is part of a premarket notification filed by Young O/s Llc with the FDA for Obtura Gutta Percha Delivery System, Model 823-700.
| Device ID | K042828 |
| 510k Number | K042828 |
| Device Name: | OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 |
| Classification | Plugger, Root Canal, Endodontic |
| Applicant | YOUNG O/S LLC 1663 FENTON BUSINESS PARK CT. Fenton, MO 63026 |
| Contact | Stephen W Conger |
| Correspondent | Stephen W Conger YOUNG O/S LLC 1663 FENTON BUSINESS PARK CT. Fenton, MO 63026 |
| Product Code | EKR |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-12 |
| Decision Date | 2004-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10843471152284 | K042828 | 000 |
| 10843471100438 | K042828 | 000 |
| 10843471100308 | K042828 | 000 |
| 10843471100285 | K042828 | 000 |