The following data is part of a premarket notification filed by Lang Dental Mfg. Co., Inc. with the FDA for Ortho-jet Crystal.
| Device ID | K112397 |
| 510k Number | K112397 |
| Device Name: | ORTHO-JET CRYSTAL |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | LANG DENTAL MFG. CO., INC. P.O BOX 969 Wheeling, IL 60090 -0969 |
| Contact | David Lang |
| Correspondent | David Lang LANG DENTAL MFG. CO., INC. P.O BOX 969 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 | 2011-08-19 |
| Decision Date | 2011-11-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7750470060 | K112397 | 000 |
| D7750470050 | K112397 | 000 |
| D7750470040 | K112397 | 000 |
| D7750470030 | K112397 | 000 |
| D7750470020 | K112397 | 000 |
| D7750470010 | K112397 | 000 |
| D6500270C0 | K112397 | 000 |