Denture Repair Kit
The Denture Repair Kit is a dental device consisting of components that allow a patient or clinician to repair a broken or cracked denture outside of a laboratory setting. It is classified as FDA Class 2, indicating moderate risk; however, per FDA guidance on convenience kits (May 20, 1997), this type of kit is under enforcement discretion and does not require a 510(k) premarket notification if it meets all criteria in the applicable guidance. The product code is EBO and the applicable regulation is 21 CFR 872.3570, under the Dental medical specialty.
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Basic Information
- Product Code
- EBO
- Device Class
- FDA class 2
- Regulation Number
- 872.3570
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 7
Device Characteristics
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K850927 | COMPLETE DENTURE REPAIR KIT | Jul 02, 1985 | Substantially Equivalent | Tooth Aid Lab, Inc. |
| K844480 | DENTAL ORAL CARE SYSTEMS & COMPONENTS | Jun 19, 1985 | Substantially Equivalent for Some Indications | Advanced Bio Systems, Inc. |
| K833057 | UNIVERSAL FIX-A-PLATE | Feb 27, 1984 | Substantially Equivalent | Laurentian Laboratories |
| K833056 | UNIVERSAL LINE-A-PLATE | Feb 27, 1984 | Substantially Equivalent | Laurentian Laboratories |
| K820685 | DENTURE ADJUSTMENT KIT | Apr 09, 1982 | Substantially Equivalent | Camdent Laboratories |
| K820245 | SAFE TDENT | Apr 09, 1982 | Substantially Equivalent | Professional Dental Studios |
| K770091 | EMERGENCY FAST-FIX DENTURE REPAIR KIT | Jan 24, 1977 | Substantially Equivalent | Mr. Clarence Hurst |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.