FDA.reportPublic FDA data

Denovo general purpose dental molar band

Primary DI
00810059290372
Brand
Denovo general purpose dental molar band
Company
Denovo Dental, Inc.
Model
160-183
Device description
Denovo general purpose dental molar band - Maxillary size U41.5
Published
2023-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ECMBand, Preformed, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECMBand, Preformed, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810059290372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810059290372008100592903728100592903720810059290372

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic metal bandA thin metal ring designed to be fitted around the contours of a tooth and cemented into place to support an orthodontic attachment (e.g., bracket, tube), brazed or soldered onto the ring, intended to be secured to the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
183498179
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810059291584Denovo Dental Crown Removing Plier800-015 2023-06-30
00810059291256Dental Matrix System Wedges180-411 2023-06-30
00810059291263Dental Matrix System Wedges180-4132023-06-30
00810059290006Denovo general purpose dental molar band160-1462023-06-30
00810059290013Denovo general purpose dental molar band160-147 2023-06-30
00810059290020Denovo general purpose dental molar band160-148 2023-06-30
00810059290037Denovo general purpose dental molar band160-1492023-06-30
00810059290044Denovo general purpose dental molar band160-150 2023-06-30
00810059290051Denovo general purpose dental molar band160-151 2023-06-30
00810059290068Denovo general purpose dental molar band160-152 2023-06-30
00810059290075Denovo general purpose dental molar band160-153 2023-06-30
00810059290082Denovo general purpose dental molar band160-154 2023-06-30
00810059290099Denovo general purpose dental molar band160-155 2023-06-30
00810059290105Denovo general purpose dental molar band160-156 2023-06-30
00810059290112Denovo general purpose dental molar band160-157 2023-06-30
00810059290129Denovo general purpose dental molar band160-158 2023-06-30
00810059290143Denovo general purpose dental molar band160-160 2023-06-30
00810059290150Denovo general purpose dental molar band160-161 2023-06-30
00810059290167Denovo general purpose dental molar band160-162 2023-06-30
00810059290174Denovo general purpose dental molar band160-163 2023-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033707035763LEONE SPALEONE SPAECM2020-11-11
08033707035770LEONE SPALEONE SPAECM2020-11-11
08033707035787LEONE SPALEONE SPAECM2020-11-11
08033707035794LEONE SPALEONE SPAECM2020-11-11
08033707035800LEONE SPALEONE SPAECM2020-11-11
08033707035817LEONE SPALEONE SPAECM2020-11-11
08033707035824LEONE SPALEONE SPAECM2020-11-11
08033707035831LEONE SPALEONE SPAECM2020-11-11
08033707035848LEONE SPALEONE SPAECM2020-11-11
08033707035855LEONE SPALEONE SPAECM2020-11-11
08033707035862LEONE SPALEONE SPAECM2020-11-11
08033707035879LEONE SPALEONE SPAECM2020-11-11
08033707035886LEONE SPALEONE SPAECM2020-11-11
08033707035893LEONE SPALEONE SPAECM2020-11-11
08033707035909LEONE SPALEONE SPAECM2020-11-11
08033707035916LEONE SPALEONE SPAECM2020-11-11
08033707035923LEONE SPALEONE SPAECM2020-11-11
08033707035930LEONE SPALEONE SPAECM2020-11-11
08033707035947LEONE SPALEONE SPAECM2020-11-11
08033707035954LEONE SPALEONE SPAECM2020-11-11
08033707035961LEONE SPALEONE SPAECM2020-11-11
08033707035978LEONE SPALEONE SPAECM2020-11-11
08033707035985LEONE SPALEONE SPAECM2020-11-11
08033707035992LEONE SPALEONE SPAECM2020-11-11
08033707036005LEONE SPALEONE SPAECM2020-11-11
08033707036012LEONE SPALEONE SPAECM2020-11-11
08033707036029LEONE SPALEONE SPAECM2020-11-11
08033707036036LEONE SPALEONE SPAECM2020-11-11
08033707036043LEONE SPALEONE SPAECM2020-11-11
08033707036050LEONE SPALEONE SPAECM2020-11-11