FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V AND Z-TONE PREFORMED PLASTIC DENTURE TEETH
K Number: K013824
·
Decision Jan 30, 2002
Classifications
1
FEI Numbers
99
Registration Numbers
99
Same Product Code
54
Applicant Total
1
Review Days
72
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V AND Z-TONE PREFORMED PLASTIC DENTURE TEETH
- K Number
- K013824
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3590
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dental Manufacturing S.P.A
- Date Received
- November 19, 2001
- Decision Date
- January 30, 2002
- Product Code
- ELM
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ELM | Denture, Plastic, Teeth | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ELM), ordered by most recent decision date.
SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S
FDA 510(k)
FDA Class 2
·Dental
DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM
FDA 510(k)
FDA Class 2
·Dental
NEW STETIC ARTIFICIAL TEETH
FDA 510(k)
FDA Class 2
·Dental
PHYSIOSTAR NFC
FDA 510(k)
FDA Class 2
·Dental
VERACIA
FDA 510(k)
FDA Class 2
·Dental
MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH
FDA 510(k)
FDA Class 2
·Dental