The following data is part of a premarket notification filed by Perflex with the FDA for Acryfree Denture Base Material And Biosens Denture Base Material.
| Device ID | K150454 |
| 510k Number | K150454 |
| Device Name: | Acryfree Denture Base Material And Biosens Denture Base Material |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | PERFLEX 7 GIBOREY ISRAEL ST., INDUSTRIAL AREA POLEG Netanya, IL 4250407 |
| Contact | Ray Kelly |
| Correspondent | Ray Kelly LICENSALE INC. 57 Lazy Brook Rd. Monroe, CT 06468 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-20 |
| Decision Date | 2015-05-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00729011050197 | K150454 | 000 |
| 07290110500818 | K150454 | 000 |
| 07290110500801 | K150454 | 000 |
| 07290110500788 | K150454 | 000 |
| 07290110500771 | K150454 | 000 |
| 07290110500733 | K150454 | 000 |
| 07290110502003 | K150454 | 000 |
| 07290110501990 | K150454 | 000 |
| 07290110501501 | K150454 | 000 |
| 07290110501495 | K150454 | 000 |
| 07290110501488 | K150454 | 000 |
| 07290110501471 | K150454 | 000 |
| 07290110501464 | K150454 | 000 |
| 07290110501457 | K150454 | 000 |
| 07290110501440 | K150454 | 000 |
| 07290110501433 | K150454 | 000 |
| 07290110501389 | K150454 | 000 |
| 07290110500825 | K150454 | 000 |
| 07290110500832 | K150454 | 000 |
| 07290110500849 | K150454 | 000 |
| 00729011050139 | K150454 | 000 |
| 07290110501563 | K150454 | 000 |
| 07290110501556 | K150454 | 000 |
| 07290110501426 | K150454 | 000 |
| 07290110501419 | K150454 | 000 |
| 07290110501402 | K150454 | 000 |
| 07290110500795 | K150454 | 000 |
| 07290110500764 | K150454 | 000 |
| 07290110500757 | K150454 | 000 |
| 07290110500740 | K150454 | 000 |
| 07290110500160 | K150454 | 000 |
| 07290110501983 | K150454 | 000 |
| 07290110501303 | K150454 | 000 |
| 07290110501297 | K150454 | 000 |
| 07290110500863 | K150454 | 000 |
| 07290110500856 | K150454 | 000 |
| 07290110501372 | K150454 | 000 |