FDA.reportPublic FDA data

Healing Cap

Primary DI
08806169105585
Brand
Healing Cap
Company
DENTIS CO. ,LTD
Model
DEWHC
Device description
Ø6.0, L:4.2mm
Published
2015-08-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082843000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082843000MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEMDentis Co., Ltd.2009-06-19DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806169105585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806169105585088061691055858806169105585

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical mesh, metallicA sterile flat woven/knitted material made of a biocompatible metal (e.g., surgical stainless steel, tantalum) with appropriate mechanical characteristics for implantation. This non-dedicated device is used alone or in combination with synthetic materials (e.g., polymers) to support or protect tissues in reconstructive surgical procedures (e.g., to repair large chest wall defects or large abdominal incisional hernias) and/or orthopaedic procedures (e.g., cranioplasty, femoral reconstruction). Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
694721181
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800313236132SQ AXEL Step DrillDSASTD54122026-05-08
08800053007115i-Clean Solid Abutment DriverDSADS2026-04-22
08800053007122i-Clean Solid Abutment DriverDSADL2026-04-22
08800053023757Bone ProfilerDBP452026-04-22
08800053023764Bone ProfilerDBP552026-04-22
08800053023771Bone ProfilerDBP652026-04-22
08800053032322Bone Profiler BaseDBPBN2026-04-22
08800053032339Bone Profiler BaseDBPBM2026-04-22
08800053032346Bone Profiler BaseDBPBR2026-04-22
08800053034340Surgical SQ KITDSQKN-12026-04-22
08800053038737I-FIX Angled Mount Adapter BodyDNAMB2026-04-22
08800053038744I-FIX Angled Mount Adapter ScrewDNAMS2026-04-22
08800053038751I-FIX Angled Mount AdapterDNAMA2026-04-22
08800053042505I-FIX Bone ProfilerDBPI402026-04-22
08800053043526SQ Guide Profiler DrillDSQGPDM2026-04-22
08800053081030Depth GaugeDSSDGN2026-04-22
08800053081047Bone PackerDSSBPN2026-04-22
08800053081054SAVE 03DSSS03N2026-04-22
08800053083041ReamerDSSR28N2026-04-22
08800053083058ReamerDSSR31N2026-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260516873062SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
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