FDA.reportPublic FDA data

DENALI

Primary DI
00810042120426
Brand
DENALI
Company
ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC
Model
681A-17B
Device description
Dontrix Force Gauge
Published
2020-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EILGauge, Depth, Instrument, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EILGauge, Depth, Instrument, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810042120426PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810042120426008100421204268100421204260810042120426

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic appliance force gaugeA hand-held dental instrument intended to be used in orthodontics to accurately measure forces (in grams or ounces) applied by the elastics or springs used when setting up orthodontic appliances within the patient's mouth. The device is typically of cylindrical or tubular design (but can be dial-shaped with circular read out) and is made of metal (some partly plastic); it contains a spring-loaded mechanism which indicates the force exerted to pull the appliance elastic or spring to the desired length. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
077801124
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810042124875OSE8007-7772026-01-28
00810042124844OSEX009-0062025-11-26
00810042124851OSEX009-0072025-11-26
00810042124868OSEX009-0082025-11-26
00869843000239Depend-On0169-0002016-07-29
00869843000277OSE0167-0002016-07-29
00869843000291OSE 8oz. Orthodontic Etching Gel - Blue240M-L002018-06-13
00810042124745OSE0202-0072023-08-11
00810042124752OSE0202-0082023-08-11
00810042124769OSE0202-0092023-08-11
00810042124738OSE0580-0122023-07-20
00810042124547OSE0202-F2023-06-21
00810042124554OSE0202-G2023-06-21
00810042124561OSE0202-H2023-06-21
00810042124578OSE0202-J2023-06-21
00810042124585OSE0202-K2023-06-21
00810042124592OSE0202-W2023-06-21
00810042124608OSE0202-Y2023-06-21
00810042124639OSE0202-N2023-06-21
00810042124646OSE0202-P2023-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810213814796EdgeEndo® EdgeVerify™HSG-S Corp.EIL2026-08-19
00810213814802EdgeEndo® EdgeVerify™HSG-S Corp.EIL2026-08-19
00810213814819EdgeEndo® EdgeVerify™HSG-S Corp.EIL2026-08-19
00810213814833EdgeEndo® EdgeVerify™HSG-S Corp.EIL2026-08-19
00810213814840EdgeEndo® EdgeVerify™HSG-S Corp.EIL2026-08-19
00810213814857EdgeEndo® EdgeVerify™HSG-S Corp.EIL2026-08-19
00810213814826EdgeEndo® EdgeVerify™HSG-S Corp.EIL2026-08-18
00810135961233ToejackNVision Biomedical Technologies, Inc.EIL2026-07-29
G149TBSB1270TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4230TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4240TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4250TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4260TBS BASICSACME ENTERPRISE.EIL2026-05-20
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