The following data is part of a premarket notification filed by Lang Dental Mfg. Co., Inc. with the FDA for Lang Dental Resincap Pattern And Coping Acrylic Resin.
| Device ID | K081705 |
| 510k Number | K081705 |
| Device Name: | LANG DENTAL RESINCAP PATTERN AND COPING 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 | 2008-06-17 |
| Decision Date | 2008-09-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D6502390RED0 | K081705 | 000 |
| D6502302R0 | K081705 | 000 |
| D6502307R0 | K081705 | 000 |
| D6502308R0 | K081705 | 000 |
| D6502309R0 | K081705 | 000 |
| D6502310RED0 | K081705 | 000 |
| D6502312RED0 | K081705 | 000 |
| D6502350RED0 | K081705 | 000 |
| D6502370RED0 | K081705 | 000 |
| D6502380RED0 | K081705 | 000 |
| D6502300L0 | K081705 | 000 |