The following data is part of a premarket notification filed by Lang Dental Mfg. Co., Inc. with the FDA for Jet Denture Repair Powder Meharry 100,454 Grams, Jet Denture Repair Professional Package 100 Grams/118ml, 1220,30,23.
Device ID | K072580 |
510k Number | K072580 |
Device Name: | JET DENTURE REPAIR POWDER MEHARRY 100,454 GRAMS, JET DENTURE REPAIR PROFESSIONAL PACKAGE 100 GRAMS/118ML, 1220,30,23 |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
Applicant | LANG DENTAL MFG. CO., INC. 175 MESSNER DR. Wheeling, IL 60090 -0969 |
Contact | Chah Shen |
Correspondent | Chah Shen LANG DENTAL MFG. CO., INC. 175 MESSNER DR. Wheeling, IL 60090 -0969 |
Product Code | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-09-13 |
Decision Date | 2007-11-05 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D6501280P10 | K072580 | 000 |
D6501234B10 | K072580 | 000 |
D6501230P10 | K072580 | 000 |
D6501230F30 | K072580 | 000 |
D6501230F20 | K072580 | 000 |
D6501230F10 | K072580 | 000 |
D6501230B10 | K072580 | 000 |
D6501223P10 | K072580 | 000 |
D6501223F30 | K072580 | 000 |
D6501223F20 | K072580 | 000 |
D6501223F10 | K072580 | 000 |
D6501223B10 | K072580 | 000 |
D6501220P10 | K072580 | 000 |
D6501220F30 | K072580 | 000 |
D6501220F20 | K072580 | 000 |
D6501220F10 | K072580 | 000 |
D6501234F10 | K072580 | 000 |
D6501234F20 | K072580 | 000 |
D6501234F30 | K072580 | 000 |
D6501280F30 | K072580 | 000 |
D6501280F20 | K072580 | 000 |
D6501280F10 | K072580 | 000 |
D6501280B10 | K072580 | 000 |
D6501270P10 | K072580 | 000 |
D6501270F30 | K072580 | 000 |
D6501270F20 | K072580 | 000 |
D6501270F10 | K072580 | 000 |
D6501270B10 | K072580 | 000 |
D6501250P10 | K072580 | 000 |
D6501250F30 | K072580 | 000 |
D6501250F20 | K072580 | 000 |
D6501250F10 | K072580 | 000 |
D6501250B10 | K072580 | 000 |
D6501234P10 | K072580 | 000 |
D6501220B10 | K072580 | 000 |