PERMA LABORATORIES

FDA Device Registration & Listing · Hinckley, OH, US · Registration 1528710

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1528710
FEI Number
1000136230
Entity Name
PERMA LABORATORIES
City/State/Country
Hinckley, OH, US
Establishment Address
120 Wakefield Run Blvd, Hinckley, OH 44233, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Manufacture Medical Device
Owner / Operator
PERMA LABORATORIES (Owner Number: 9006672)
Owner / Operator Contact Address
120 Wakefield Run Blvd., --, Hinckley, OH 44233, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K121318
PMA Number
N/A

All Registered Proprietary Names

Perma Soft Denture Reliner Fizz-It Denture Cleaner P.E.R.K. Perma Soft Denture Reliner ProSoft Denture Reliner

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EBP Reliner, Denture, Over The Counter Dental Class 2 872.3560 2007-11-05
EFT Cleanser, Denture, Over The Counter Dental Class 1 872.3520 2018-06-11
EBO Denture Repair Kit Dental Class 2 872.3570 2007-11-05
EBP Reliner, Denture, Over The Counter Dental Class 2 872.3560 2012-06-21

Official Correspondent

Melissa Lima

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PERMA LABORATORIES
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K902838 Denture Dynamic'S, Inc. DENTURE DYNAMIC'S DENTURE MAGIC 1990-09-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1528710. Last updated year: 2026. Please use registration number 1528710 when referencing this establishment in official correspondence.
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