ORTHO ARCH

GUDID D90970011713

ANTERIOR BITE RAMP 3MM TIPS & HANDLE (8)

Ortho Arch Company Inc

Dental mould

• Primary Device ID: D90970011713
• NIH Device Record Key: 812d172f-130f-46d2-9239-268470715e94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHO ARCH
• Version Model Number: 700-117
• Company DUNS: 020956330
• Company Name: Ortho Arch Company Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	D90970011713 [Primary]

FDA Product Code

• ECQ: Aligner, Bracket, Orthodontic

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: 2025-09-05
• Device Publish Date: 2025-08-28

On-Brand Devices [ORTHO ARCH]

• D909800083N1: SPECTRUM ULTIMATE HOOK CRIMPING PLIER
• D9098000781: LITE 3/8' DBL ENDED SLB BRACKET WIRE DIRECTOR/ OPENING TOOL - BLUE HANDLE
• D9098000761: BRACKETIZER - BLUE HANDLE
• D9098000751: CINCH BACK/ DISTAL BENDER - BLUE HANDLE
• D9098000731: POLAR BEAR MARTENSITIC POSITIONER
• D9098000711: PRECISION LIGATURE DIRECTOR - BLUE HANDLE
• D909800070W1: MOSQUITO HEMOSTAT - FINE TIP
• D909800070H1: MOSQUITO HEMOSTAT - FINE TIP
• D909800070C1: MOSQUITO HEMOSTAT - CURVED
• D9098000691: DBL ENDED ELASTIC REMOVER - BLUE HANDLE
• D9098000641: LITE 1/4' BAND PUSHER/ SCALER - BLUE HANDLE
• D9098000481: HEAVY BAND PUSHER
• D9092700011: .010 KOBAYASHI HOOKS (100) **WHILE SUPPLIES LAST. DISCONTINUED ITEM. NON-REFUNDABLE**
• D9092604781: .0195 LEVEL 3 TWIST SS - 30' SPOOL***DISCONTINUED/ WHILE SUPPLIES LAST. NON-REFUNDABLE OR RETURN
• D9092604771: .0175 LEVEL 3 TWIST SS - 30' SPOOL***DISCONTINUED/ WHILE SUPPLIES LAST. NON-REFUNDABLE OR RETURN
• D9092604761: .0155 LEVEL 3 TWIST SS - 30' SPOOL***DISCONTINUED/ WHILE SUPPLIES LAST. NON-REFUNDABLE OR RETURN
• D9092604581: .018 X .025 LOWER LEVEL 3 TWIST SS RIGHT FORM WIRES (10) ***DISCONTINUED/ WHILE SUPPLIES LAST. N
• D90926045014: .017 X .025 UPPER LEVEL 3 TWIST SS RIGHT FORM WIRES (10) ***DISCONTINUED/ WHILE SUPPLIES LAST. N
• D90926044619: .016 X .022 LOWER LEVEL 3 TWIST SS RIGHT FORM WIRES (10) ***DISCONTINUED/ WHILE SUPPLIES LAST. N
• D909250177D1: .016 X 025 SS DAMON FORM
• D909250149D1: .021 X .025 SS DAMON FORM
• D9092501041: .016 x .016 Stainless Steel Arches Right form Goldtone Upper
• D909228025D1: .016 X .025 BETA TITANIUM DAMON FORM
• D9092280250D1: 16X25 Beta-T Damon Form (100pk)
• D9092280200D1: 19X25 Beta-T Damon Form (100pk)
• D909228014D1: .017 X .025 BETA TITANIUM DAMON FORM
• D90922692018: .019 X .025 UPPER NITINOL MULTI-MODULUS WITH DIMPLE**WHILE SUPPLIES LAST. DISCONTINUED ITEM. NON
• D90922691219: .016 X .022 UPPER NITINOL MULTI-MODULUS WITH DIMPLE**WHILE SUPPLIES LAST. DISCONTINUED ITEM. NON
• D9092268151: .017 X .025 LOWER MULTI MODULUS NITINOL RIGHT FORM (10) ***DISCONTINUED/ WHILE SUPPLIES LAST. NO
• D9092266691: .019 X .025 LOWER BLACK SATIN SE NITINOL - DIMPLE (10)***DISCONTINUED/ WHILE SUPPLIES LAST. NON-
• D9092266661: .018 X .025 UPPER BLACK SATIN SE NITINOL - DIMPLE (10)***DISCONTINUED/ WHILE SUPPLIES LAST. NON-
• D9092266571: .018 LOWER BLACK SATIN SE NITINOL WITH DIMPLE (10)***DISCONTINUED/ WHILE SUPPLIES LAST. NON-REFU
• D9092266561: .018 UPPER BLACK SATIN SE NITINOL WITH DIMPLE (10)***DISCONTINUED/ WHILE SUPPLIES LAST. NON-REFU
• D909226424D1: .020 X .020 NITINOL HEAT ACTIVATED DAMON FORM (10)
• D909226420CD1: .019 X .025 HA NITINOL WITH COPPER DAMON FORM (10)
• D90922641901: 018x025 Lower Nitinol Heat Activated RIGHT Form (100)
• D909226412D1: .016X.022 NITINOL HEAT ACTIVATED DAMON FORM
• D909226412CD1: .016X022 HEAT ACTIVATED NITINOL WITH COPPER DAMON FORM (10)
• D909226406017: .018 UPPER NITI HEAT ACTIVATED RIGHT FORM (100)
• D909226405016: 016 LOWER NITI HEAT ACTIVATED RIGHT FORM (100)
• D909226404015: .016 UPPER NITI HEAT ACTIVATED RIGHT FORM (100)
• D909226403014: .014 Lower Heat Activated Nitinol Right Form (100)
• D909226402013: .014 Upper Heat Activated Nitinol Right Form (100)
• D909226401012: .012 Lower Heat Activated Nitinol Right Form (100)
• D90922622213: .021 X ,025 UPPER REVERSE CURVE OF SPEE (10)**WHILE SUPPLIES LAST. DISCONTINUED ITEM. NON-REFUND
• D90922620312: .014 LOWER REVERSE CURVE OF SPEE (10) **WHILE SUPPLIES LAST. DISCONTINUED ITEM. NON-REFUNDABLE**
• D90922620110: .012 LOWER REVERSE CURVE OF SPEE (10) **WHILE SUPPLIES LAST. DISCONTINUED ITEM. NON-REFUNDABLE**
• D90910374214: .017 X .025 RIGHT FORM KEYHOLE 2-LOOP 42MM (10)
• D90980103211: SUPER GLASS MIRROR - BUCCAL
• D90980103110: SUPER GLASS MIRROR - LINGUAL