FDA 510(k)

Neodent 可掃描式治療基座

K 號：K253922 · 2026-06-15

申請人JJGC Indústria e Comércio de Materiais Dentários S.A.

決定日期2026-06-15

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

Neodent Scannable Healing Abutment is the device name listed in this FDA 510(k) record. The listed applicant is JJGC Indústria e Comércio de Materiais Dentários S.A.. It received FDA 510(k) clearance on 2026-06-15 under 510(k) number K253922. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Neodent Scannable Healing Abutment?

Neodent Scannable Healing Abutment is a medical device that received FDA 510(k) clearance on 2026-06-15. The listed applicant is JJGC Indústria e Comércio de Materiais Dentários S.A.. The 510(k) number is K253922.

When did Neodent Scannable Healing Abutment receive FDA 510(k) clearance?

Neodent Scannable Healing Abutment received FDA 510(k) clearance on 2026-06-15, under 510(k) number K253922.

Who is the listed applicant for Neodent Scannable Healing Abutment?

The FDA 510(k) record lists JJGC Indústria e Comércio de Materiais Dentários S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Neodent Scannable Healing Abutment?

The FDA product code for Neodent Scannable Healing Abutment is NHA.