FDA.report

Johnson-Promident

Primary DI
10843471112554
Brand
Johnson-Promident
Company
Young Innovations, Inc.
Model
ACR-J662M
Catalog number
ACR-J662M
Device description
ACRYLIC POLISHERS HP JUMBO MEDIUM GRIT
Published
2022-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EHLPOINT, ABRASIVE

Product Code Classifications

CodeDeviceSpecialtyClass
EHLPoint, AbrasiveDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10843471112554PackageGS16In Commercial Distribution
00843471112557PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084347111255410843471112554
00843471112557008434711125578434711125570843471112557

GMDN Terms

TermDefinition
Dental abrasive point, reusableA rotary endpiece designed to be attached to a dental power tool handpiece to produce an abrasive rotation typically for polishing and smoothing natural or restorative dental materials (e.g., crown) during a dental procedure. Also referred to as a polisher, it is available in various forms (e.g., conical), sizes, and materials [e.g., silicone, rubber, metal, diamond, silicon carbide, aluminium oxide]. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1 (800) 210-8945customerservice@younginnovations.com

Regulatory Flags

DUNS number
004193103
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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10840326426200Young Specialties2000-02-102000-02-102026-01-26
10840326426217Young Specialties2000-03-102000-03-102026-01-26
10840326426224Young Specialties2000-04-102000-04-102026-01-26
10840326426231Young Specialties2000-05-102000-05-102026-01-26
10840326426248Young Specialties2000-06-102000-06-102026-01-26
10840326426255Young Specialties2000-07-102000-07-102026-01-26
10840326426262Young Specialties2000-08-102000-08-102026-01-26
10840326426279Young Specialties2000-09-102000-09-102026-01-26
10840326426286Young Specialties2000-10-102000-10-102026-01-26
10840326426293Young Specialties2000-15-102000-15-102026-01-26
00840326426302Young Specialties2000-16-102000-16-102026-01-26
10840326426316Young Specialties2000-17-102000-17-102026-01-26
10840326426323Young Specialties2000-18-102000-18-102026-01-26
10840326426330Young Specialties2000-19-102000-19-102026-01-26
10840326426347Young Specialties2000-20-102000-20-102026-01-26
10840326426354Young Specialties2000-21-102000-21-102026-01-26
10840326426361Young Specialties2000-22-102000-22-102026-01-26
10840326426378Young Specialties2000-23-102000-23-102026-01-26
10840326426385Young Specialties2000-24-102000-24-102026-01-26
10840326426392Young Specialties2000-25-102000-25-102026-01-26

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