The following data is part of a premarket notification filed by Lang Dental Mfg. Co., Inc. with the FDA for Mach 4 Jet Tooth Shade Provisonal Crown And Bridge Acrylic Resin.
| Device ID | K083195 |
| 510k Number | K083195 |
| Device Name: | MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN |
| Classification | Crown And Bridge, Temporary, Resin |
| 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 | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-29 |
| Decision Date | 2009-06-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D650383081M0 | K083195 | 000 |
| D6503820DRK0 | K083195 | 000 |
| D6503820CLR0 | K083195 | 000 |
| D650382081M0 | K083195 | 000 |
| D650382069M0 | K083195 | 000 |
| D650382066M0 | K083195 | 000 |
| D650382065M0 | K083195 | 000 |
| D650382062M0 | K083195 | 000 |
| D650382060M0 | K083195 | 000 |
| D6503820LGT0 | K083195 | 000 |
| D6503820LI0 | K083195 | 000 |
| D650383069M0 | K083195 | 000 |
| D650383066M0 | K083195 | 000 |
| D650383065M0 | K083195 | 000 |
| D650383062M0 | K083195 | 000 |
| D650383060M0 | K083195 | 000 |
| D650383059M0 | K083195 | 000 |
| D6503820OM10 | K083195 | 000 |
| D6503820MED0 | K083195 | 000 |
| D650382059M0 | K083195 | 000 |
| D650381262M0 | K083195 | 000 |
| D6503810OM10 | K083195 | 000 |
| D650381060M0 | K083195 | 000 |
| D650381059M0 | K083195 | 000 |
| D6503808M0 | K083195 | 000 |
| D6503807M0 | K083195 | 000 |
| D6503804M0 | K083195 | 000 |
| D6503804F0 | K083195 | 000 |
| D6503803M0 | K083195 | 000 |
| D6503803F0 | K083195 | 000 |
| D650381062M0 | K083195 | 000 |
| D650381065M0 | K083195 | 000 |
| D6503810MED0 | K083195 | 000 |
| D6503810LI0 | K083195 | 000 |
| D6503810LGT0 | K083195 | 000 |
| D6503810DRK0 | K083195 | 000 |
| D6503810CLR0 | K083195 | 000 |
| D650381081M0 | K083195 | 000 |
| D650381069M0 | K083195 | 000 |
| D650381066M0 | K083195 | 000 |
| D6503802X60 | K083195 | 000 |
| D6503830CLR0 | K083195 | 000 |
| D65038H0OM10 | K083195 | 000 |
| D65038H062M0 | K083195 | 000 |
| D65038H060M0 | K083195 | 000 |
| D65038H059M0 | K083195 | 000 |
| D6503893P0 | K083195 | 000 |
| D6503893M0 | K083195 | 000 |
| D6503893F0 | K083195 | 000 |
| D6503893C0 | K083195 | 000 |
| D6503870OM10 | K083195 | 000 |
| D65038H065M0 | K083195 | 000 |
| D65038H066M0 | K083195 | 000 |
| D65038H0MED0 | K083195 | 000 |
| D65038H0MED | K083195 | 000 |
| D65038H0LI0 | K083195 | 000 |
| D65038H0LGT0 | K083195 | 000 |
| D65038H0DRK0 | K083195 | 000 |
| D65038H0CLR0 | K083195 | 000 |
| D65038H081M0 | K083195 | 000 |
| D65038H069M0 | K083195 | 000 |
| D6503870CLR0 | K083195 | 000 |
| D650387081M0 | K083195 | 000 |
| D650387069M0 | K083195 | 000 |
| D650385065M0 | K083195 | 000 |
| D650385062M0 | K083195 | 000 |
| D650385060M0 | K083195 | 000 |
| D650385059M0 | K083195 | 000 |
| D6503830OM10 | K083195 | 000 |
| D6503830MED0 | K083195 | 000 |
| D6503830LI0 | K083195 | 000 |
| D6503830LGT0 | K083195 | 000 |
| D650385066M0 | K083195 | 000 |
| D650385069M0 | K083195 | 000 |
| D650387066M0 | K083195 | 000 |
| D650387065M0 | K083195 | 000 |
| D650387062M0 | K083195 | 000 |
| D650387060M0 | K083195 | 000 |
| D650387059M0 | K083195 | 000 |
| D6503850OM10 | K083195 | 000 |
| D6503850CLR0 | K083195 | 000 |
| D650385081M0 | K083195 | 000 |
| D6503830DRK0 | K083195 | 000 |