BC Plus
FDA 510(k) K043562 · Vericom Co., Ltd.
510(k) numberK043562
Submission
- Device name
- BC Plus
- Applicant
- Vericom Co., Ltd.
Anyang-Si, Gyeonggi-Do, KR - Received
- December 27, 2004
- Decision date
- January 3, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was BC Plus cleared by the FDA?
BC Plus (K043562) received a 510(k) decision of Substantially Equivalent on January 3, 2005, 7 days after the submission was received.
What is the product code of K043562?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.