AxioComp NT

GUDID D161230370

Axiodent Inc.

Dental composite resin kit

• Primary Device ID: D161230370
• NIH Device Record Key: b2803351-741f-4ca0-836f-e9768484a021
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AxioComp NT
• Version Model Number: 23037 Refill Pack Shade B3
• Company DUNS: 119330625
• Company Name: Axiodent Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D161230370 [Primary]

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-19
• Device Publish Date: 2024-11-11

On-Brand Devices [AxioComp NT]

• D161230550: 23055 20 x 0.25g unit dose compules Shade A2
• D161230540: 23054 Refill Pack Shade Gingival G4
• D161230530: 23053 Refill Pack Shade Gingival G3
• D161230520: 23052 Refill Pack Shade Gingival G2
• D161230510: 23051 Refill Pack Shade Gingival G1
• D161230500: 23050 Refill Pack Shade Bleach
• D161230490: 23049 Refill Pack Shade Extra Bleach
• D161230480: 23048 Refill Pack Shade OA3
• D161230470: 23047 Refill Pack Shade OA2
• D161230460: 23046 Refill Pack Shade OA1
• D161230450: 23045 Refill Pack Shade Opaque
• D161230440: 23044 Refill Pack Shade Incisal
• D161230430: 23043 Refill Pack Shade D3
• D161230420: 23042 Refill Pack Shade D2
• D161230410: 23041 Refill Pack Shade D1
• D161230400: 23040 Refill Pack Shade C3
• D161230390: 23039 Refill Pack Shade C2
• D161230380: 23038 Refill Pack Shade C1
• D161230370: 23037 Refill Pack Shade B3
• D161230360: 23036 Refill Pack Shade B2
• D161230350: 23035 Refill Pack Shade B1
• D161230340: 23034 Refill Pack Shade A4
• D161230330: 23033 Refill Pack Shade A3.5
• D161230320: 23032 Refill Pack Shade A3
• D161230310: 23031 Refill Pack Shade A2
• D161230780: 23078 20 x 0.25g unit dose compules Shade Gingival
• D161230770: 23077 20 x 0.25g unit dose compules Shade Gingival
• D161230760: 23076 20 x 0.25g unit dose compules Shade Gingival
• D161230750: 23075 20 x 0.25g unit dose compules Shade Gingival
• D161230740: 23074 20 x 0.25g unit dose compules Shade Bleach
• D161230730: 23073 20 x 0.25g unit dose compules Shade Extra Bl
• D161230720: 23072 20 x 0.25g unit dose compules Shade OA3
• D161230710: 23071 20 x 0.25g unit dose compules Shade OA2
• D161230700: 23070 20 x 0.25g unit dose compules Shade OA1
• D161230690: 23069 20 x 0.25g unit dose compules Shade Opaque
• D161230680: 23068 20 x 0.25g unit dose compules Shade Incisal
• D161230670: 23067 20 x 0.25g unit dose compules Shade D3
• D161230660: 23066 20 x 0.25g unit dose compules Shade D2
• D161230650: 23065 20 x 0.25g unit dose compules Shade D1
• D161230640: 23064 20 x 0.25g unit dose compules Shade C3
• D161230630: 23063 20 x 0.25g unit dose compules Shade C2
• D161230620: 23062 20 x 0.25g unit dose compules Shade C1
• D161230610: 23061 20 x 0.25g unit dose compules Shade B3
• D161230600: 23060 20 x 0.25g unit dose compules Shade B2
• D161230590: 23059 20 x 0.25g unit dose compules Shade B1
• D161230580: 23058 20 x 0.25g unit dose compules Shade A4
• D161230570: 23057 20 x 0.25g unit dose compules Shade A3.5
• D161230560: 23056 20 x 0.25g unit dose compules Shade A3