The following data is part of a premarket notification filed by Nsi with the FDA for Nsi Hexed And Non-hexed Implant System.
| Device ID | K003620 |
| 510k Number | K003620 |
| Device Name: | NSI HEXED AND NON-HEXED IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NSI 10565 LEE HIGHWAY SUITE 100 Fairfax,, VA 22030 |
| Contact | Greta M Hols |
| Correspondent | Greta M Hols NSI 10565 LEE HIGHWAY SUITE 100 Fairfax,, VA 22030 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-22 |
| Decision Date | 2001-09-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D768EPCEX402KT0 | K003620 | 000 |
| D768WB60 | K003620 | 000 |
| D768WB40 | K003620 | 000 |
| D768WB30 | K003620 | 000 |
| D768WB20 | K003620 | 000 |
| D768TCB1NH0 | K003620 | 000 |
| D768TCB1H0 | K003620 | 000 |
| D768SCU20 | K003620 | 000 |
| D768IBS850 | K003620 | 000 |
| D768AMC10 | K003620 | 000 |
| D768AMC17D30 | K003620 | 000 |
| D768EPCEX401KT0 | K003620 | 000 |
| D768DB50 | K003620 | 000 |
| D768DB350 | K003620 | 000 |
| D768DB20 | K003620 | 000 |
| D768AMC40 | K003620 | 000 |
| D768AMC30D40 | K003620 | 000 |
| D768AMC30 | K003620 | 000 |
| D768AMC20 | K003620 | 000 |
| D768IBS70 | K003620 | 000 |
| D768IBS150 | K003620 | 000 |
| D768IBS130 | K003620 | 000 |
| 06009544027935 | K003620 | 000 |
| 06009544027928 | K003620 | 000 |
| 06009544021643 | K003620 | 000 |
| 06009544021636 | K003620 | 000 |
| 06009544027867 | K003620 | 000 |
| 06009544027843 | K003620 | 000 |
| 06009544008552 | K003620 | 000 |
| 06009544008484 | K003620 | 000 |
| 06009544027942 | K003620 | 000 |
| 06009544027959 | K003620 | 000 |
| D768IBS1150 | K003620 | 000 |
| D768IBS100 | K003620 | 000 |
| D768IBN850 | K003620 | 000 |
| D768IBN180 | K003620 | 000 |
| D768IBN150 | K003620 | 000 |
| D768IBN130 | K003620 | 000 |
| D768IBN1150 | K003620 | 000 |
| D768IBN100 | K003620 | 000 |
| 06009544008460 | K003620 | 000 |
| 06009544021742 | K003620 | 000 |
| 06009544010180 | K003620 | 000 |
| 06009544010173 | K003620 | 000 |
| 06009544010166 | K003620 | 000 |
| 06009544010159 | K003620 | 000 |
| 06009544010142 | K003620 | 000 |
| 06009544010135 | K003620 | 000 |
| 06009544010128 | K003620 | 000 |
| 06009544010111 | K003620 | 000 |
| 06009544010197 | K003620 | 000 |
| 06009544010203 | K003620 | 000 |
| 06009544021735 | K003620 | 000 |
| 06009544021582 | K003620 | 000 |
| 06009544021575 | K003620 | 000 |
| 06009544021568 | K003620 | 000 |
| 06009544021551 | K003620 | 000 |
| 06009544010234 | K003620 | 000 |
| 06009544010227 | K003620 | 000 |
| 06009544010210 | K003620 | 000 |
| 06009544009269 | K003620 | 000 |
| 06009544009252 | K003620 | 000 |
| 06009544009245 | K003620 | 000 |
| 06009544000990 | K003620 | 000 |
| 06009544000983 | K003620 | 000 |
| 06009544000976 | K003620 | 000 |
| 06009544000969 | K003620 | 000 |
| 06009544000952 | K003620 | 000 |
| D768SB17TT0 | K003620 | 000 |
| D768SB160 | K003620 | 000 |
| D768GCNX400 | K003620 | 000 |
| 06009544001003 | K003620 | 000 |
| 06009544001010 | K003620 | 000 |
| 06009544009238 | K003620 | 000 |
| 06009544009221 | K003620 | 000 |
| 06009544009214 | K003620 | 000 |
| 06009544007166 | K003620 | 000 |
| 06009544007159 | K003620 | 000 |
| 06009544007111 | K003620 | 000 |
| 06009544007104 | K003620 | 000 |
| 06009544001027 | K003620 | 000 |
| D768GCEX400 | K003620 | 000 |