FDA.reportPublic FDA data

Denovo chairside space maintainer band

Primary DI
00810059292642
Brand
Denovo chairside space maintainer band
Company
Denovo Dental, Inc.
Model
8385-283
Device description
Denovo chairside space maintainer band - Mandibular size L38.5
Published
2023-06-26
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
DYTMaintainer, Space Preformed, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYTMaintainer, Space Preformed, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810059292642PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810059292642008100592926428100592926420810059292642

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic space maintainerA dental prosthetic replacement for prematurely lost deciduous teeth intended to prevent closure of the space before eruption of the permanent successors. It is often an urgent necessity in the buccal segment to prevent impaction of the permanent teeth and other complications.

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
08906154840993e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841006e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841013e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841020e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841037e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841044e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841051e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841068e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841075e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841082e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841099e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841105e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841112e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841129e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841136e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841143e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841150e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841167e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841174e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841181e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841198e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841204e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841211e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841228e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841235e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841242e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841259e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841266e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841273e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841280e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26