The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Opal Prime & Opal Bond/orthodontic Bracket System, Models 2626, 2625, 2635, 2803, 2802.
Device ID | K071055 |
510k Number | K071055 |
Device Name: | OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802 |
Classification | Bracket, Plastic, Orthodontic |
Applicant | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
Contact | Robert Wang |
Correspondent | Robert Wang ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
Product Code | DYW |
CFR Regulation Number | 872.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2007-04-16 |
Decision Date | 2007-05-03 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00883205107305 | K071055 | 000 |
00883205107299 | K071055 | 000 |