The following data is part of a premarket notification filed by Lang Dental Mfg. Co., Inc. with the FDA for Tempo Cushion Treatment Denture Reline Acrylic Resin Liquid, Professional Size Package And Powder.
| Device ID | K081514 |
| 510k Number | K081514 |
| Device Name: | TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | LANG DENTAL MFG. CO., INC. 175 MESSNER DR. Wheeling, IL 60090 -0969 |
| Contact | Chah M Shen |
| Correspondent | Chah M 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 | 2008-05-30 |
| Decision Date | 2008-09-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D6501050P10 | K081514 | 000 |
| D6501034P10 | K081514 | 000 |
| D6501030P10 | K081514 | 000 |
| D6501023P10 | K081514 | 000 |
| D6501020P10 | K081514 | 000 |
| D6501070P10 | K081514 | 000 |