FDA.reportPublic FDA data

Intrace USA

Primary DI
00850083275662
Brand
Intrace USA
Company
PILOTIS TECH LLC
Model
ANE-07-340
Catalog number
ANE-07-340
Device description
Hollenback #3 Carver, Double-Ended, 1.5 mm Blades, Flat/Angled Pattern, Stainless Steel, Reusable.
Published
2026-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKDInstrument, Cutting, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKDInstrument, Cutting, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850083275662PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850083275662008500832756628500832756620850083275662

GMDN Terms#

Term, Definition table
TermDefinition
Manual dental scaler, reusableA hand-held dental instrument designed for removing calculus and other accretions from the surface and between the teeth during dental cleaning and periodontal (gum) therapy. It is typically designed as a one-piece instrument with a pointed, distal end of various shapes and sizes. Also known as a periodontic scaler, it can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
6124230756info@intrace.us

Regulatory Flags#

DUNS number
110680677
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850083275006Intrace USA03-004-14003-004-1402026-07-03
00850083275013Intrace USA03-022-14003-022-1402026-07-03
00850083275037Intrace USA03-097-14503-097-1452026-07-03
00850083275044Intrace USA70-10-2570-10-252026-07-03
00850083275051Intrace USA03-182-11003-182-1102026-07-03
00850083275068Intrace USA03-316-13003-316-1302026-07-03
00850083275075Intrace USA04-002-09004-002-0902026-07-03
00850083275082Intrace USA04-012-12504-012-1252026-07-03
00850083275099Intrace USA04-029-16004-029-1602026-07-03
00850083275105Intrace USA04-030-14004-030-1402026-07-03
00850083275112Intrace USA04-056-20004-056-2002026-07-03
00850083275129Intrace USA04-070-18004-070-1802026-07-03
00850083275136Intrace USA04-082-16004-082-1602026-07-03
00850083275143Intrace USA04-214-18004-214-1802026-07-03
00850083275150Intrace USA04-240-13004-240-1302026-07-03
00850083275167Intrace USA04-273-26004-273-2602026-07-03
00850083275174Intrace USA05-004-14505-004-1452026-07-03
00850083275181Intrace USA05-011-11505-011-1152026-07-03
00850083275198Intrace USA05-013-14505-013-1452026-07-03
00850083275204Intrace USA05-087-15505-087-1552026-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783008333Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-02
00348783008340Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-02
00348783008357Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-02
00348783012248Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-02
00348783008265Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-01
00348783008272Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-01
00348783008289Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-01
00348783008319Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-01
00840018635838NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635845NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635852NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635869NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635876NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635883NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635890NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635906NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635913NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635920NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635937NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635944NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635951NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635968NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635975NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635982NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635999NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018636002NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018636019NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018636026NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018636033NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018636040NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02