MODIFICATION OF PROMPT L-POP— 510(k) K992048

Substantially Equivalent

Espe Dental AG

FDA 510(k) clearance K992048 for MODIFICATION OF PROMPT L-POP, Substantially Equivalent on 1999-08-16. Applicant: Espe Dental AG. Device class: 2.

Clearance details

Applicant: Espe Dental AG
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 1999-06-17
Decision date: 1999-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bavaria D-82228 Seefeld, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLE

K260485 — Any-Etch2026-05-14
K260430 — Porcelain Etch Gel2026-04-10
K252450 — Adhese 22026-03-05
K260682 — Bond-PR Universal Adhesive2026-03-03
K251587 — VITA VMLC Primer2026-02-23

More clearances from Espe Dental AG

K011394 — LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM2001-06-29
K011154 — ELIPAR FREELIGHT2001-05-16
K002793 — KETAC CEM U2000-09-26
K002364 — PROTEMP H2000-08-10
K001494 — MODIFICATION TO PROMPT L-POP2000-07-07

Recalls naming K992048

K-number listed on FDA's recall record

Z-0797-2025 — 3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit box) Transbond Plus Self Etching Primer is an orthodontic all-in-one etchant and primer that is used in the bonding process of orthodontic appliances to teeth.Class II·Ongoing·3M Unitek Corporation·20241126

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K992048.

Data sourced from openFDA. This site is unofficial and independent of the FDA.