The following data is part of a premarket notification filed by Lang Dental Manufacturing Company, Inc with the FDA for Jet Set 4 Denture Repair Resin.
| Device ID | K152981 |
| 510k Number | K152981 |
| Device Name: | JET SET 4 DENTURE REPAIR RESIN |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | LANG DENTAL MANUFACTURING COMPANY, INC 175 MESSNER DRIVE Wheeling, IL 60090 |
| Contact | David Lang |
| Correspondent | David Lang LANG DENTAL MANUFACTURING COMPANY, INC 175 MESSNER DRIVE Wheeling, IL 60090 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-09 |
| Decision Date | 2016-09-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D65047H0P10 | K152981 | 000 |
| D6504720P10 | K152981 | 000 |
| D6504723F20 | K152981 | 000 |
| D6504723P10 | K152981 | 000 |
| D6504730F20 | K152981 | 000 |
| D6504730P10 | K152981 | 000 |
| D6504734F20 | K152981 | 000 |
| D6504734P10 | K152981 | 000 |
| D65047H0F20 | K152981 | 000 |
| D6504720F20 | K152981 | 000 |