The following data is part of a premarket notification filed by Sterilex Corp. with the FDA for Ultra-kleen Powder For Dental Unit Water Lines, Models 513p, 505l.
| Device ID | K991946 |
| 510k Number | K991946 |
| Device Name: | ULTRA-KLEEN POWDER FOR DENTAL UNIT WATER LINES, MODELS 513P, 505L |
| Classification | Unit, Operative Dental |
| Applicant | STERILEX CORP. 7-I GWYNNS HILL COURT Owins Mills, MD 21117 |
| Contact | Shira Kramer |
| Correspondent | Shira Kramer STERILEX CORP. 7-I GWYNNS HILL COURT Owins Mills, MD 21117 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-09 |
| Decision Date | 1999-09-03 |