The following data is part of a premarket notification filed by Glenwood, Llc. with the FDA for Impact Air 45 Handpiece For Endodontic Use.
| Device ID | K972375 |
| 510k Number | K972375 |
| Device Name: | IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | GLENWOOD, LLC. ONE NEW ENGLAND AVE. Piscataway, NJ 08855 |
| Contact | John I Gruen |
| Correspondent | John I Gruen GLENWOOD, LLC. ONE NEW ENGLAND AVE. Piscataway, NJ 08855 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-25 |
| Decision Date | 1997-09-10 |
| Summary: | summary |