The following data is part of a premarket notification filed by Lang Dental Mfg. Co., Inc. with the FDA for Jet Xr Radiopaque Acrylic Resin Powder 45 Grams, Jet Xr Radiopaque Acrylic Resin Powder 100 Grams, Jet Liquid 118 Ml Mod.
| Device ID | K100653 |
| 510k Number | K100653 |
| Device Name: | JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | LANG DENTAL MFG. CO., INC. 175 MESSNER DR. Wheeling, IL 60090 -0969 |
| Contact | David Lang |
| Correspondent | David Lang 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 | 2010-03-08 |
| Decision Date | 2010-10-08 |
| Summary: | summary |