The following data is part of a premarket notification filed by Jedental Co., Inc. with the FDA for Jedental Vlc Dental Curing Light.
Device ID | K935718 |
510k Number | K935718 |
Device Name: | JEDENTAL VLC DENTAL CURING LIGHT |
Classification | Light, Fiber Optic, Dental |
Applicant | JEDENTAL CO., INC. 324 SECOND ST. PIKE Southampton, PA 18966 |
Contact | John Wong |
Correspondent | John Wong JEDENTAL CO., INC. 324 SECOND ST. PIKE Southampton, PA 18966 |
Product Code | EAY |
CFR Regulation Number | 872.4620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-11-30 |
Decision Date | 1994-01-26 |