The following data is part of a premarket notification filed by Dental Manufacturing S.p.a with the FDA for Acry Plus, Acry Lux, Acry Lux V, Acry Rock, Acry Rock V And Z-tone Preformed Plastic Denture Teeth.
| Device ID | K013824 |
| 510k Number | K013824 |
| Device Name: | ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V AND Z-TONE PREFORMED PLASTIC DENTURE TEETH |
| Classification | Denture, Plastic, Teeth |
| Applicant | DENTAL MANUFACTURING S.P.A 13 RED FOX LN. Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls DENTAL MANUFACTURING S.P.A 13 RED FOX LN. Littleton, CO 80127 |
| Product Code | ELM |
| CFR Regulation Number | 872.3590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-19 |
| Decision Date | 2002-01-30 |