Product Code: KZP FDA class 2 21 CFR 872.3750

Solution, Cement Dissolving

Dental

The Dental Cement Dissolving Solution is a chemical agent used to soften or dissolve dental cement that has been used to fix crowns, bridges, or other fixed restorations, facilitating their removal without causing damage to the underlying tooth structure. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KZP, regulated under 21 CFR 872.3750, in the Dental medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

510(k)s
2
FEI Numbers
1
Registration Numbers
1
Unique Applicants
2
Years Active
15

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Basic Information

Product Code
KZP
Device Class
FDA class 2
Regulation Number
872.3750
Medical Specialty
Dental
Review Panel
DE
Submission Type
1

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K920843 TOOTH CONDITIONER
K771974 SOLVENEX I-0

FEI Numbers

This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.