FDA.reportPublic FDA data

Health-Tec X-Ray Head Sleeves

Primary DI
D773660HT15261
Brand
Health-Tec X-Ray Head Sleeves
Company
Dental Health Products Inc
Model
660-HT1526
Catalog number
660-HT1526
Device description
"Health-Tec X-Ray Head Sleeves, 15"" x 26"""
Published
2017-01-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PEMDental Barriers And Sleeves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEMDental Barriers And SleevesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160232000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160232000Disposable Barrier Sleeves and CoversDentsply International, Inc.2016-06-07PEM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D773660HT15263HPackageHIBCC4In Commercial Distribution
D773660HT15261PrimaryHIBCC0
D773660HT15260Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Instrument/equipment drape, single-use, non-sterileA non-sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various instruments/equipment (e.g., dental chairs, treatment tables), to provide a barrier against cross-contamination in the home or healthcare facility. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-626-2163mhull@dhpi.net

Regulatory Flags#

DUNS number
623191194
Device count
250
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D773210HT40A121DHP Nanohybrid Composite210-HT40A12210-HT40A122022-10-20
D773210HT40A221DHP Nanohybrid Composite210-HT40A22210-HT40A222022-10-20
D773210HT40A321DHP Nanohybrid Composite210-HT40A32210-HT40A322022-10-20
D773210HT40A3521DHP Nanohybrid Composite210-HT40A352210-HT40A3522022-10-20
D773210HT40B121DHP Nanohybrid Composite210-HT40B12210-HT40B122022-10-20
D773210HT40B221DHP Nanohybrid Composite210-HT40B22210-HT40B222022-10-20
D773210HT40C221DHP Nanohybrid Composite210-HT40C22210-HT40C222022-10-20
D773210HT40C321DHP Nanohybrid Composite210-HT40C32210-HT40C322022-10-20
D773210HT50A120DHP Nanohybrid Composite210-HT50A12210-HT50A122022-10-20
D773210HT50A220DHP Nanohybrid Composite210-HT50A22210-HT50A222022-10-20
D773210HT50A320DHP Nanohybrid Composite210-HT50A32210-HT50A322022-10-20
D773210HT50A3520DHP Nanohybrid Composite210-HT50A352210-HT50A3522022-10-20
D773210HT50B120DHP Nanohybrid Composite210-HT50B12210-HT50B122022-10-20
D773210HT50C320DHP Nanohybrid Composite210-HT50C32210-HT50C322022-10-20
D773210HT10A121DHP Nanohybrid Flowable Composite210-HT10A12210-HT10A122022-10-19
D773210HT10A221DHP Nanohybrid Flowable Composite210-HT10A22210-HT10A222022-10-19
D773210HT10A321DHP Nanohybrid Flowable Composite210-HT10A32210-HT10A322022-10-19
D773210HT10A3521DHP Nanohybrid Flowable Composite210-HT10A352210-HT10A3522022-10-19
D773210HT10A421DHP Nanohybrid Flowable Composite210-HT10A42210-HT10A422022-10-19
D773210HT10B121DHP Nanohybrid Flowable Composite210-HT10B12210-HT10B122022-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456214459JMUJMU DENTAL, INCPEM2026-07-10
00840456214466JMUJMU DENTAL, INCPEM2026-07-10
00840456214473JMUJMU DENTAL, INCPEM2026-07-10
00840456214480JMUJMU DENTAL, INCPEM2026-07-10
00840456214497JMUJMU DENTAL, INCPEM2026-07-10
00840456214503JMUJMU DENTAL, INCPEM2026-07-10
00840456217931JMUJMU DENTAL, INCPEM2026-07-10
00840456217948JMUJMU DENTAL, INCPEM2026-07-10
00840456217955JMUJMU DENTAL, INCPEM2026-07-10
00840456217962JMUJMU DENTAL, INCPEM2026-07-10
00840456217979JMUJMU DENTAL, INCPEM2026-07-10
00840456217986JMUJMU DENTAL, INCPEM2026-07-10
00840456214305JMUJMU DENTAL, INCPEM2026-07-06
00840456214312JMUJMU DENTAL, INCPEM2026-07-06
00840456214329JMUJMU DENTAL, INCPEM2026-07-06
00840456214336JMUJMU DENTAL, INCPEM2026-07-06
00840456214343JMUJMU DENTAL, INCPEM2026-07-06
00840456214350JMUJMU DENTAL, INCPEM2026-07-06
00840456214367JMUJMU DENTAL, INCPEM2026-07-06
00840456214374JMUJMU DENTAL, INCPEM2026-07-06
00840456214381JMUJMU DENTAL, INCPEM2026-07-06
00840456214398JMUJMU DENTAL, INCPEM2026-07-06
00840456214404JMUJMU DENTAL, INCPEM2026-07-06
00840456214411JMUJMU DENTAL, INCPEM2026-07-06
00840456214428JMUJMU DENTAL, INCPEM2026-07-06
00840456214435JMUJMU DENTAL, INCPEM2026-07-06
00840456214442JMUJMU DENTAL, INCPEM2026-07-06
00840456215265JMUJMU DENTAL, INCPEM2026-07-06
00840456215746JMUJMU DENTAL, INCPEM2026-07-06
00840456217184JMUJMU DENTAL, INCPEM2026-07-06