The following data is part of a premarket notification filed by Astron Dental Corp. with the FDA for 2nd Modified Vinylac Press Pack Denture Resin.
| Device ID | K874025 |
| 510k Number | K874025 |
| Device Name: | 2ND MODIFIED VINYLAC PRESS PACK DENTURE RESIN |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | ASTRON DENTAL CORP. 280 HOLDBROOK DR. Wheeling, IL 60090 |
| Contact | R. E Muller |
| Correspondent | R. E Muller ASTRON DENTAL CORP. 280 HOLDBROOK DR. Wheeling, IL 60090 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-02 |
| Decision Date | 1987-12-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D810PUFMCSEK11 | K874025 | 000 |
| D810PUFCLREK11 | K874025 | 000 |
| D810PUF99SEK11 | K874025 | 000 |
| D810PUF99LK11 | K874025 | 000 |
| D810PUF99EK11 | K874025 | 000 |
| D810PLTELSEK11 | K874025 | 000 |
| D810PLTELEK11 | K874025 | 000 |
| D810PLTDFPFSEK11 | K874025 | 000 |
| D810PLTDFPFEK11 | K874025 | 000 |
| D810PLTCLRSEK11 | K874025 | 000 |
| D810PLTCLREK11 | K874025 | 000 |
| D810PLT99SEK11 | K874025 | 000 |
| D810PUFCLRLK11 | K874025 | 000 |
| D810PUFCLRSEK11 | K874025 | 000 |
| D810PUFMCLK1 | K874025 | 000 |
| D810PUFMCEK11 | K874025 | 000 |
| D810PUFMCDARKSEK11 | K874025 | 000 |
| D810PUFMCDARKLK11 | K874025 | 000 |
| D810PUFMCDARKEK11 | K874025 | 000 |
| D810PUFELSEK11 | K874025 | 000 |
| D810PUFELLK11 | K874025 | 000 |
| D810PUFELEK11 | K874025 | 000 |
| D810PUFDFPFSEK11 | K874025 | 000 |
| D810PUFDFPFLK11 | K874025 | 000 |
| D810PUFDFPFEK11 | K874025 | 000 |
| D810PLT99EK11 | K874025 | 000 |