The following data is part of a premarket notification filed by Megagen Co., Ltd. with the FDA for Ball Abutment System.
| Device ID | K101890 |
| 510k Number | K101890 |
| Device Name: | BALL ABUTMENT SYSTEM |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | MEGAGEN CO., LTD. 325 N. PUENTE STREET UNIT B Brea, CA 92821 |
| Contact | Joyce Bang |
| Correspondent | Joyce Bang MEGAGEN CO., LTD. 325 N. PUENTE STREET UNIT B Brea, CA 92821 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-07 |
| Decision Date | 2011-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806388232611 | K101890 | 000 |
| 08806388214761 | K101890 | 000 |
| 08806388214006 | K101890 | 000 |
| 08806388213993 | K101890 | 000 |
| 08806388213986 | K101890 | 000 |
| 08806388213979 | K101890 | 000 |
| 08806388213009 | K101890 | 000 |
| 08806388212996 | K101890 | 000 |
| 08806388212989 | K101890 | 000 |
| 08806388212972 | K101890 | 000 |
| 08806388212965 | K101890 | 000 |
| 08806388212958 | K101890 | 000 |
| 08806388212941 | K101890 | 000 |
| 08806388212934 | K101890 | 000 |
| 08806388212927 | K101890 | 000 |
| 08806388214778 | K101890 | 000 |
| 08806388214785 | K101890 | 000 |
| 08806388232604 | K101890 | 000 |
| 08806388232598 | K101890 | 000 |
| 08806388232581 | K101890 | 000 |
| 08806388232444 | K101890 | 000 |
| 08806388232437 | K101890 | 000 |
| 08806388232420 | K101890 | 000 |
| 08806388232413 | K101890 | 000 |
| 08806388232406 | K101890 | 000 |
| 08806388232390 | K101890 | 000 |
| 08806388214839 | K101890 | 000 |
| 08806388214822 | K101890 | 000 |
| 08806388214815 | K101890 | 000 |
| 08806388214808 | K101890 | 000 |
| 08806388214792 | K101890 | 000 |
| 08806388212910 | K101890 | 000 |