The following data is part of a premarket notification filed by Mycone Dental Supply Co., Inc. (a/k/a Keystone Ind with the FDA for Millenium Sledgehammer, Formula 99 And Naturalyke H.c., High Impact Denture Acrylic.
| Device ID | K983876 |
| 510k Number | K983876 |
| Device Name: | MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | MYCONE DENTAL SUPPLY CO., INC. (A/K/A KEYSTONE IND 616 HOLLYWOOD AVE. Cherry Hill, NJ 08002 |
| Contact | Larry Steffier |
| Correspondent | Larry Steffier MYCONE DENTAL SUPPLY CO., INC. (A/K/A KEYSTONE IND 616 HOLLYWOOD AVE. Cherry Hill, NJ 08002 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-02 |
| Decision Date | 1998-12-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H66810019721 | K983876 | 000 |
| H66810005411 | K983876 | 000 |
| H66810005401 | K983876 | 000 |
| H66810005391 | K983876 | 000 |
| H66810005361 | K983876 | 000 |
| H66810005351 | K983876 | 000 |
| H66810005231 | K983876 | 000 |
| H66810005221 | K983876 | 000 |
| H66810005211 | K983876 | 000 |
| H66810005181 | K983876 | 000 |
| H66810005171 | K983876 | 000 |
| H66810005161 | K983876 | 000 |
| H66810005151 | K983876 | 000 |
| H66810005141 | K983876 | 000 |
| H66810005131 | K983876 | 000 |
| H66810005431 | K983876 | 000 |
| H66810005441 | K983876 | 000 |
| H66810005451 | K983876 | 000 |
| H66810019711 | K983876 | 000 |
| H66810019701 | K983876 | 000 |
| H66810019671 | K983876 | 000 |
| H66810019661 | K983876 | 000 |
| H66810019651 | K983876 | 000 |
| H66810019631 | K983876 | 000 |
| H66810019621 | K983876 | 000 |
| H66810019611 | K983876 | 000 |
| H66810005911 | K983876 | 000 |
| H66810005901 | K983876 | 000 |
| H66810005491 | K983876 | 000 |
| H66810005481 | K983876 | 000 |
| H66810005471 | K983876 | 000 |
| H66810005461 | K983876 | 000 |
| H66810005121 | K983876 | 000 |
| H66810005111 | K983876 | 000 |
| H66810005101 | K983876 | 000 |
| H66810004861 | K983876 | 000 |
| H66810004851 | K983876 | 000 |
| H66810004841 | K983876 | 000 |
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| H66810004821 | K983876 | 000 |
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| H66860100181 | K983876 | 000 |
| H66860100161 | K983876 | 000 |
| H66860100151 | K983876 | 000 |
| H66860100141 | K983876 | 000 |
| H66860100111 | K983876 | 000 |
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| H66860100031 | K983876 | 000 |
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| H66860100261 | K983876 | 000 |
| H66860100271 | K983876 | 000 |
| H66860100481 | K983876 | 000 |
| H66860100461 | K983876 | 000 |
| H66860100451 | K983876 | 000 |
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| H66860100421 | K983876 | 000 |
| H66860100401 | K983876 | 000 |
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| H66810143311 | K983876 | 000 |
| H66810143301 | K983876 | 000 |
| H66810019731 | K983876 | 000 |