FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES— 510(k) K945200
Substantially EquivalentProcter & Gamble Co.
FDA 510(k) clearance K945200 for FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES, Substantially Equivalent on 1994-11-30. Applicant: Procter & Gamble Co.. Device class: 1.
Clearance details
- Applicant
- Procter & Gamble Co.
- Product code
- Code KOO
- Device class
- Class 1
- Regulation
- 21 CFR 872.3490
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cincinnati, OH, US
Recent devices under product code KOO
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view all- K141018 — ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT
- K131543 — TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED
- K091281 — TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA
- K091964 — CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS
- K081555 — TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED
Recalls naming K945200
K-number listed on FDA's recall record- Z-0263-2024 — FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ADH CREAM WITH SCOPE 2OZ, SKU 906402 FIXODENT ORG CREAM TRAVEL .75OZ, SKU 901239
- Z-1538-2022 — FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ORG CREAM TRAVEL .75OZ, SKU 901239
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K945200.
Data sourced from openFDA. This site is unofficial and independent of the FDA.