PEAK SE, MODEL 5135— 510(k) K063558
Substantially EquivalentUltradent Products, Inc.
FDA 510(k) clearance K063558 for PEAK SE, MODEL 5135, Substantially Equivalent on 2006-12-14. Applicant: Ultradent Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Ultradent Products, Inc.
- Product code
- Code KLE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3200
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- South Jordan, UT, US
Recent devices under product code KLE
view allMore clearances from Ultradent Products, Inc.
view allRecalls naming K063558
K-number listed on FDA's recall record- Z-1368-2022 — Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Primer 4pk Refill, Part: 5135; Peak Universal Bond Sample SE, Part: S4554. For use in light-curing dental bonding procedures.
- Z-1822-2012 — Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with black and blue print writing. Product code: 5135, 872.3200 KLE, liquid and powder mixture is a syringe-in-a-syringe delivery system. The product is used for most bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure composites, namely PermaFlo DC. Peak SE does not require a separate etching step for quality adhesion. Peak SE is also conducive for bonding to: Dentin and enamel, porcelain, metal and composite.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K063558.
Data sourced from openFDA. This site is unofficial and independent of the FDA.