Device Classification Name |
Zinc Oxide Eugenol
|
510(k) Number |
K120695 |
Device Name |
DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT |
Applicant |
DENTIST IN A BOX PTY. LTD |
44 HORACE ST |
MALVERN, VICTORIA,
AU
3144
|
|
Applicant Contact |
JOHN BANKY |
Correspondent |
DENTIST IN A BOX PTY. LTD |
44 HORACE ST |
MALVERN, VICTORIA,
AU
3144
|
|
Correspondent Contact |
JOHN BANKY |
Regulation Number | 872.3275
|
Classification Product Code |
|
Date Received | 03/07/2012 |
Decision Date | 06/12/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|