The following data is part of a premarket notification filed by Diamodent with the FDA for Ucla And Universal Abutments.
| Device ID | K010619 |
| 510k Number | K010619 |
| Device Name: | UCLA AND UNIVERSAL ABUTMENTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | DIAMODENT 2737 EAST REGAL PARK AVE. Anaheim, CA 92806 |
| Contact | Jeff Rassoli |
| Correspondent | Jeff Rassoli DIAMODENT 2737 EAST REGAL PARK AVE. Anaheim, CA 92806 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-01 |
| Decision Date | 2001-09-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D907K2000 | K010619 | 000 |
| D907S9102 | K010619 | 000 |
| D907S8010 | K010619 | 000 |
| D907S8000 | K010619 | 000 |
| D907S7500 | K010619 | 000 |
| D907S7000 | K010619 | 000 |
| D907R9102 | K010619 | 000 |
| D907R9002 | K010619 | 000 |
| D907R8010 | K010619 | 000 |
| D907B1010 | K010619 | 000 |
| D907B2010 | K010619 | 000 |
| D907B5000 | K010619 | 000 |
| D907K1010 | K010619 | 000 |
| D907D5100 | K010619 | 000 |
| D907C5100 | K010619 | 000 |
| D907C5000 | K010619 | 000 |
| D907C4010 | K010619 | 000 |
| D907C2010 | K010619 | 000 |
| D907C2000 | K010619 | 000 |
| D907C1000 | K010619 | 000 |
| D907R8000 | K010619 | 000 |
| D907R7500 | K010619 | 000 |
| D907R7000 | K010619 | 000 |
| D907C9000 | K010619 | 000 |
| D907C7500 | K010619 | 000 |
| D907C7000 | K010619 | 000 |
| D907B9000 | K010619 | 000 |
| D907B6601 | K010619 | 000 |
| D907B6000 | K010619 | 000 |
| D907R12000 | K010619 | 000 |
| D907P12000 | K010619 | 000 |
| D907D7000 | K010619 | 000 |
| D907D7500 | K010619 | 000 |
| D907D9000 | K010619 | 000 |
| D907P9102 | K010619 | 000 |
| D907P9002 | K010619 | 000 |
| D907P8010 | K010619 | 000 |
| D907P8000 | K010619 | 000 |
| D907P7500 | K010619 | 000 |
| D907P7000 | K010619 | 000 |
| D907P6552 | K010619 | 000 |
| D907N6500 | K010619 | 000 |
| D907S12000 | K010619 | 000 |
| D907P6800 | K010619 | 000 |
| D907R5250 | K010619 | 000 |
| D907R5200 | K010619 | 000 |
| D907R5150 | K010619 | 000 |
| D907R5100 | K010619 | 000 |
| D907R5050 | K010619 | 000 |
| D907R4011 | K010619 | 000 |
| D907R2010 | K010619 | 000 |
| D907R2000 | K010619 | 000 |
| D907S10000 | K010619 | 000 |
| D907S10010 | K010619 | 000 |
| D907S1010 | K010619 | 000 |
| D907S5150 | K010619 | 000 |
| D907S5100 | K010619 | 000 |
| D907S5050 | K010619 | 000 |
| D907S2010 | K010619 | 000 |
| D907S2000 | K010619 | 000 |
| D907S1100 | K010619 | 000 |
| D907S10110 | K010619 | 000 |
| D907S10100 | K010619 | 000 |
| D907R1100 | K010619 | 000 |
| D907R10110 | K010619 | 000 |
| D907R10100 | K010619 | 000 |
| D907P1100 | K010619 | 000 |
| D907P10110 | K010619 | 000 |
| D907P10100 | K010619 | 000 |
| D907P1010 | K010619 | 000 |
| D907P10010 | K010619 | 000 |
| D907P10000 | K010619 | 000 |
| D907K5000 | K010619 | 000 |
| D907K4010 | K010619 | 000 |
| D907P2000 | K010619 | 000 |
| D907P2012 | K010619 | 000 |
| D907P4011 | K010619 | 000 |
| D907R1010 | K010619 | 000 |
| D907R10010 | K010619 | 000 |
| D907R10000 | K010619 | 000 |
| D907P5250 | K010619 | 000 |
| D907P5200 | K010619 | 000 |
| D907P5150 | K010619 | 000 |
| D907P5100 | K010619 | 000 |
| D907P5050 | K010619 | 000 |
| D907K2010 | K010619 | 000 |