Device Classification Name |
mouthguard, prescription
|
510(k) Number |
K024261 |
Device Name |
DENTAL PROTECTOR |
Applicant |
DENTAL CONCEPTS LLC. |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760
|
|
Applicant Contact |
HOWARD HOLSTEIN |
Correspondent |
DENTAL CONCEPTS LLC. |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760
|
|
Correspondent Contact |
HOWARD HOLSTEIN |
Classification Product Code |
|
Date Received | 12/23/2002 |
Decision Date | 03/26/2003 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|