Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- DZSCapsule, Dental, Amalgam1Product Code
- DYHAdhesive, Bracket And Tooth Conditioner, Resin2Product Code
- DZEImplant, Endosseous, Root-Form2Product Code
- EBCSealant, Pit And Fissure, And Conditioner2Product Code
- EBDCoating, Filling Material, Resin2Product Code
- EBECoating, Denture Hydrophilic, Resin2Product Code
- EBFMaterial, Tooth Shade, Resin2Product Code
- EBGCrown And Bridge, Temporary, Resin2Product Code
- EBHMaterial, Impression Tray, Resin1Product Code
- EBIResin, Denture, Relining, Repairing, Rebasing2Product Code
- EBLPin, Retentive And Splinting, And Accessory Instruments1Product Code
- EBODenture Repair Kit2Product Code
- EBPReliner, Denture, Over The Counter2Product Code
- EFDAmalgamator, Dental, Ac-Powered1Product Code
- EFTCleanser, Denture, Over The Counter1Product Code
- EGGAttachment, Precision, All1Product Code
- EHEDispenser, Mercury And/Or Alloy1Product Code
- EHOBar, Preformed1Product Code
- EHPClasp, Preformed1Product Code
- EHQCusp, Preformed1Product Code
- EHRPad, Denture, Over The Counter2Product Code
- EHSCushion, Denture, Over The Counter2Product Code
- EITApplicator, Rapid Wax, Dental2Product Code
- EJHAlloy, Metal, Base2Product Code
- EJJAlloy, Amalgam2Product Code
- EJKLiner, Cavity, Calcium Hydroxide2Product Code
- EJLBur, Dental1Product Code
- EJPArticulators1Product Code
- EJSAlloy, Other Noble Metal2Product Code
- EJTAlloy, Gold-Based Noble Metal2Product Code
- EJWClasp, Wire1Product Code
- EJXAnchor, Preformed1Product Code
- EKLPoint, Silver, Endodontic1Product Code
- EKMGutta-Percha1Product Code
- EKNPoint, Paper, Endodontic1Product Code
- EKODenture Preformed (Partially Prefabricated Denture)2Product Code
- ELEImplant, Subperiosteal2Product Code
- ELJTeeth, Artificial, Posterior With Metal Insert1Product Code
- ELKTeeth, Artificial, Backing And Facing1Product Code
- ELLTeeth, Porcelain2Product Code
- ELMDenture, Plastic, Teeth2Product Code
- ELNTeeth, Preformed Gold Denture1Product Code
- ELOCusp, Gold And Stainless Steel1Product Code
- ELRPost, Root Canal1Product Code
- ELSSplint, Endodontic Stabilizing2Product Code
- ELWMaterial, Impression2Product Code
- ELYMercury2Product Code
- ELZCrown, Preformed1Product Code
- EMACement, Dental2Product Code
- EMBZinc Oxide Eugenol1Product Code
- JERCleaner, Denture, Mechanical1Product Code
- KCRFacebow1Product Code
- KCSPantograph1Product Code
- KIFResin, Root Canal Filling2Product Code
- KLEAgent, Tooth Bonding, Resin2Product Code
- KOLAdhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer1Product Code
- KOMAdhesive, Denture, Acacia And Karaya With Sodium Borate1Product Code
- KONAdhesive, Denture, Polyacrylamide Polymer (Modified Cationic)3Product Code
- KOOAdhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt1Product Code
- KOPAdhesive, Denture, Karaya1Product Code
- KOQAdhesive, Denture, Carboxymethylcellulose Sodium (40-100&)1Product Code
- KORAdhesive, Denture, Karaya With Sodium Borate3Product Code
- KOSAdhesive, Denture, Carboxymethylcellulose Sodium And Cationic Polyacrylamide Polymer3Product Code
- KOTCarboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium1Product Code
- KXRApplicator, Resin1Product Code
- KXWAdhesive, Denture, Carboxymethylcellulose Sodium (49%) And Ethylene-Oxide Homopolymer1Product Code
- KXXAdhesive, Denture, Karaya And Ethylene-Oxide Homopolymer1Product Code
- KXYPolyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce3Product Code
- KZNScanner, Color2Product Code
- KZOInk, Arch Tracing1Product Code
- KZPSolution, Cement Dissolving2Product Code
- LBHVarnish, Cavity2Product Code
- LPKBone Grafting Material, For Dental Bone Repair2Product Code
- LYCBone Grafting Material, Synthetic2Product Code
- LZDJoint, Temporomandibular, Implant3Product Code
- MMTResin, Root Canal Filling Containing Chloroform3Product Code
- MMUAdhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight3Product Code
- MPIGlenoid Fossa Prosthesis3Product Code
- MPJInterarticular Disc Prosthesis (Interpositional Implant)3Product Code
- MPLMandibular Condyle Prosthesis3Product Code
- MZWDental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief2Product Code
- NDPAccessories, Implant, Dental, Endosseous1Product Code
- NFEMaterials, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Alveolar Ridge Augmentation2Product Code
- NHAAbutment, Implant, Dental, Endosseous2Product Code
- NKJCushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter1Product Code
- NMEBur, Diamond Coated, Reprocessed1Product Code
- NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations2Product Code
- NPKBarrier, Synthetic, Intraoral2Product Code
- NPLBarrier, Animal Source, Intraoral2Product Code
- NPMBone Grafting Material, Animal Source2Product Code
- NPZBone Grafting Material, Dental, With Biologic Component3Product Code
- NQABiologic Material, Dental3Product Code
- NRQBlade-Form Endosseous Dental Implant2Product Code
- NUNBone Grafting Material, Human Source2Product Code
- NUXCleanser, Denture, Prescription1Product Code
- NYDEndodontic Kit2Product Code
- OATImplant, Endosseous, Orthodontic2Product Code
- NYEFixture Mount Kit1Product Code
- OFWRestorative Instrument And Component Tray2Product Code
- OFYDental Implant Surgical Tray1Product Code
- OIVDental Amalgam2Product Code
- PHRDiammine Silver Fluoride Dental Hypersensitivity Varnish2Product Code
- PMEExternal Cleaning Solution2Product Code
- PNPDental Abutment Design Software For Dental Laboratory2Product Code
- POWCrown And Bridge, Long-Term Temporary, Resin2Product Code
- PZYAdditively Manufactured, Preformed, Resin Denture Tooth2Product Code
- QJKIntraoral Camera2Product Code
- QRQNon-Irrigation Endosseous Dental Implant Drill Bits1Product Code
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
External Cleaning Solution
- Page Type
- Product Code
- Definition
- For use on dental restorations, external to the mouth, prior to insertion into the mouth.
- Physical State
- Solution consists of a gel or liquid that is applied directly to the dental restoration.
- Technical Method
- Applied manually by applicator to the dental restoration, then rinsed thoroughly with water and air dried before placement in the mouth.
- Target Area
- The target area of the body is a tooth which will have the dental restoration applied to it.
- Regulation Medical Specialty
- Dental
- Review Panel
- Dental
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 2
- Regulation Number
- 872.3260
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 872.3260 Cavity varnish
§ 872.3260 Cavity varnish.
(a) Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.
(b) Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
[52 FR 30097, Aug. 12, 1987, as amended at 84 FR 71812, Dec. 30, 2019]