FDA.reportPublic FDA data

CareOne

Primary DI
00041520021250
Brand
CareOne
Company
Ahold U.S.A., Inc.
Model
SQY
Device description
Dental Tools
Published
2020-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EAXMirror, Mouth
EMNScaler, Periodontic
JETPick, Massaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAXMirror, MouthDental1
EMNScaler, PeriodonticDental1
JETPick, MassagingDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10041520921250PackageGS172In Commercial Distribution
00041520021250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1004152092125010041520921250
00041520021250000415200212500415200212500041520021250

GMDN Terms#

Term, Definition table
TermDefinition
Dental mirror, reusableA hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. This is a reusable device.

Regulatory Flags#

DUNS number
170199058
Device count
1
Premarket exempt
true
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00041520078438CareOne0415200784382019-08-30
00041520010704CareOne0415200107042019-06-28
00041520013965CareOne0415200139652020-09-27
00041520014009CareOne0415200140092019-06-28
00041520019714CareOne0415200197142019-06-28
00041520089298CareOne0415200892982019-07-31
00041520089304CareOne0415200893042019-06-28
00041520096777CareOne0415200967772019-07-31
00041520096784CareOne0415200967842019-07-31
00041520096791CareOne0415200967912019-06-28
00041520096821CareOne0415200968212019-06-28
00041520125033CareOne0415201250332019-07-31
00041520875754CareOne0415208757542019-06-28
00041520877710CareOne0415208777102019-06-28
00041520877727CareOne0415208777272019-06-28
00041520880963CareOne0415208809632019-06-28
00341520317170CareOne3415203171702020-09-27
00341520877889CareOne3415208778892019-07-31
00041520171283Care OneDigital Pregnancy Test2021-04-22
00041520171269Care OneOne Step Pregnancy Test2021-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456225424JMUJMU DENTAL, INCEAX2026-10-14
00840456225431JMUJMU DENTAL, INCEAX2026-10-14
00840161312174Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-10-12
00840161312181Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-10-12
00840161312198Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-10-12
00840456224861JMUJMU DENTAL, INCEMN2026-09-30
00840456224878JMUJMU DENTAL, INCEMN2026-09-30
00840456224885JMUJMU DENTAL, INCEMN2026-09-30
00840456224892JMUJMU DENTAL, INCEMN2026-09-30
00840456224908JMUJMU DENTAL, INCEMN2026-09-30
00840456224915JMUJMU DENTAL, INCEMN2026-09-30
D955MM5CSFS1Paul BandittTerlain Enterprises, Inc.EAX2026-09-25
06973042242995Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243008Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
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06973042243022Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
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06973042243091Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
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06973042243121Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243138Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243145Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243152Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243169Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30